DR AMBEDKAR DISSERTATION
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Transcript of DR AMBEDKAR DISSERTATION
THE TAMIL NADU DR.AMBEDKAR LAW UNIVERSITY
CHENNAI
PATENTING ON LIVING ORGANISMS: POLICY ISSUES
CONCERN AND INTRENATIONAL TRENDS
DISSERTATION SUBMITTED TO
THE TAMIL NADU DR. AMBEDKAR LAW UNIVERSITY
IN THE PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR
THE COMPLETION OF THE DEGREE OF
MASTER OF LAW
IN
INTEELECTUAL PROPERTY LAW
UNDER THE GUIDANCE AND SUPERVISION OF
Dr.A.RAGHUNADHA REDDY,M.L.,Ph.D.,M.B.A
HoD, Dept. of International Law & Organisation, HoD i/c, Dept. of
Intellectual Property Rights.
Submitted by:
G.SILAMBARASAN
REG. No: ILP1214
BATCH: 2013-2014
THE TAMIL NADU DR. AMBEDKAR LAW UNIVERSITY
POOMPOZHIL, #5, GREENWAYS ROAD, CHENNAI – 600 028.
DECLARATION
I do hereby declare that the Dissertation work titled “PATENTING ON LIVING
ORGANISMS: POLICY ISSUES AND CONCERN INTERNATIONAL TRENDS
”has been prepared by me under the eminent supervision and guidance of
Dr.A.RAGHUNADHA REDDY,M.L.,Ph.D.,M.B.A HoD, Dept. of
International Law & Organisation, HoD i/c, Dept. of Intellectual
Property Rights. Post Graduate Department, The Tamil Nadu Dr. Ambedkar
Law University, Chennai – 28, and this work has not been submitted elsewhere
for any other degree or diploma or fellowship or any other title to any candidate
of any university.
Place: Chennai G.SILAMBARASAN
Date: M.L.,
INTELLECTUAL PROPERTY LAW
Dr.A.RAGHUNADHA REDDY,M.L.,Ph.D.,M.B.A.
HoD, Dept. of International Law & Organisation,
HoD i/c, Dept. of Intellectual Property Rights.
Tamil Nadu Dr. Ambedkar Law University, Chennai – 28.
CERTIFICATE
This is to certify that this Dissertation entitled “PATENTING ON
LIVING ORGANISMS:POLICY ISSUES AND CONCERNS INTERNATIONAL
TRENDS ” is an original work of G.SILAMBARASAN in partial fulfillment
of the requirement for THE DEGREE OF MASTER OF LAW in
INTELLECTUAL PROPERTY LAW during the academic year 2013 – 2014
under my guidance and supervision in the Post Graduate Department of Law,
The Tamil Nadu Dr. Ambedkar Law University, Chennai – 28. This
Dissertation work has not been submitted elsewhere for any other degree.
Place: Chennai
Date:
ACKNOWLEDGMENT
First and foremost I thank ALMIGHTY for blessing me with enormous strength
and knowledge to complete this Dissertation work successfully.
The outcome of this present Dissertation work has been possible only with the help of the
support, inspiration and academic assistance from various people. I express my heartfelt
thanks to my Prof. Dr.A.RAGHUNADHA REDDY,M.L.,Ph.D.,M.B.A. HoD, Dept. of
International Law & Organisation, HoD i/c, Dept. of Intellectual Property Rights.The
Tamilnadu Dr.Ambedkar Law University, Chennai, for his scholarly guidance and
inspiration. With deep sense of gratitude, I render my hearty thanks to my Tmt. Lucky
George Assistant professor, The Tamil Nadu Dr. Ambedkar Law University, Chennai,
for her valuable guidance and support given to me at every stage of my Dissertation work.
I am also thankful for the assistance provided by the staffs of The Tamil Nadu
Dr.Ambedkar Law University Library, Connemera Public Library, Egmore and Anna
Centenary Library, kotturpuram, Chennai, in completing my Dissertation work.
Finally, I am grateful to my beloved parents and friends, who have always inspired
me and whose affection and blessings has always been my guiding beacon.
CONTENTS
CHAPTERS
CONTENTS
PAGE NO
CHAPTER 1
INTRODUCTION
10-24
CHAPTER 2
ORIGIN AND DEVELOPMENT OF
RESTORATIVE JUSTICE
25-51
CHAPTER 3
RESTORATIVE JUSTICE IN
INTERNATIONAL SPHERE
52-77
CHAPTER 4
VICTIMS AND RESTORATIVE JUSTICE
78-99
CHAPTER 5
RESTORATIVE JUSTICE: A CRITICAL
ASSESSMENT
100-127
CHAPTER 6 CONCLUSION AND SUGGESTIONS 128-132
BIBLIOGRAPHY
133
WEBLIOGRAPHY
134
List of abbreviations
1. CBD - Convention on Biological Diversity
2. DNA - Deoxyribonucleic Acid
3. EC - European Community
4. ECJ - European Court of Justice
5. EPC - European Patent Convention
6. EPO - European Patent Office
7. EU - European Union
8. IPC - Intellectual Property Code
9. IPRs - Intellectual Property Rights
10. GATT - General Agreement on Tariffs and Trade
11. GMO s - Genetically Modified Organisms
12. IPRs - Intellectual Property Rights
13. UK - United Kingdom
14. UNCTAD - United Nations Conference on Trade and
Development
15. The UPOV - convention The International
Convention for the Protection of Varieties of Plants
16. WIPO - World Intellectual Property Organisation
17. WTO - World Trade Organisation
18. EC - The council of the European
community
19. EFB - The European Federation of
Biotechnology
20. EST - Essential sequence tags
21. HUGO - Human genome organization
22. ICMR - Council of Medical Research
23. A - Adenine
24. Cdna - Complementary DNA
25. CSIR - Council of Scientific and Industrial
Research
26. G - Guanine
27. GM - Genetically Modifed
28. GMO - Genetically Modified Organism
29. HBGF - Heparin Binding Growth Factor
30. HIF - Gamma: Human Immune Interferon
Gamma
31. Hgh - Human Growth Hormone
32. hINV - Human Involucrin Gene
33. HN - Hemagglutinin-Neuraminidas
34. IFN - Interferon
35. IGF - Insuling-like Growth Factor
36. IPC - International Patent Classification
37. IPO - Indian Patent Office
38. JPO - Japanese Patent Office
39. kd - Kilo Dalton
40. mRNA - messenger RNA
41. M.W. - molecular weight
42. MPPP – Manual of Patent Practice and Procedure
43. NDA - New Drug Application
44. NDV - Newcastle Disease Virus
45. NIH - National Institute of Health
46. OECD - Organization of Economic Cooperation and
Development
47. ORF - Open Reading Frame
48. PCK - Polycystic Kidney
50. PCT - Patent Cooperation Treaty
51. PTO - US Patent and Trademark Office
52. PTP - Protein Tyrosine Phosphatase
53. PTP-PEST -Protein Tyrosine Phosphatases - Proline (P),
Glutamic acid (E),
Serine (S) and Threonine (T)
54. rDNA - Recombinant DNA
55. rEpo - gamma Erythropoietin
56. RFLP - Restriction Fragment Length
Polymorphism
57. RNA - Ribonucleic Acid
58. RT - Reverse Transcriptase
59. SDS-PAGE - Sodium Dodecyl Sulphate
Polyacrylamide Gel Electrophoresis
60. SNP - Single Nucleotide Polymorphism
61.STS - Sequence Tagged Sites
62.T - Thymine
63.T-DNA - Transferred DNA
64.TI - Tumor Inducing
65.TM - Trans Membrane
66.TRIPs - Agreement on Trade Related Aspects of Intellectual Property
Rights
67.tRNA - Transfer RNA
68.U - Uracil
69.UK - United Kingdom
70.US - United States
71.USA - United States of America
72. USC - United State Code
73. USCA - United State Code Annotated
74. USPQ - United States Patent Quarterly
75. USPTO or PTO - United States Patent and Trademark Office
76. WARF - Wisconsin Alumni Research Foundation
77. WIPO - World Intellectual Property Organization
78. YAC - Yeast Artificial Chromosome
79. PCR - Polymerase Chain Reaction
80. uEPO - mew Erythropoeitin
PREFACE
This work has been carried out as a part of completion of masters’ degree focusing
on the rights of victims in the criminal justice system. The presentation of a paper on,
Victim’s Rights: Discarded Under Indian Criminal Justice System, in the National
Criminological Conference held in Dr. Ambedkar Law University, Chennai, has inspired
me to work more on the plight of crime victims. On studying the victims’ rights and issues
in India, I came to understand that except the victim compensation scheme and the
compounding of offences there is no specific provision to deal with the participation of
victims in criminal proceedings. The thought of doing a research in this area has been
lingering my mind for a year, till I get the opportunity of working on it in my dissertation.
As the research work started with operating on restitution and reparation for crime victims,
it is my guide who introduced me the term called “Restorative Justice” and advised me to
concentrate on it. When I started searching resources on it, I found the development and
practice of restorative justice in other countries to a great degree.
As a victim-centred justice the models adopted to address the interests of crime
victims is excellent and notable. The time and cost incurred in conventional criminal trials
can be evaded by applying restoration ideals and principles. It can be stated that restorative
justice is a best alternative to the traditional criminal trial. My research work centred on
analyzing the principles of restorative justice, its practice in international arena, its impact
on crime victims, offenders and community, its benefits and limits and finally conclusion
with some suggestions. In India adopting the concept of restorative justice will help in
facing the challenges posed by the failures in present criminal justice administration and
the same can be implemented along with the existing criminal court process in the
adjudication of criminal matters.
TABLE OF CASES
1.European Court in Relaxin case.
2. In Amgen v. Chugai pharmaceuticals
3. Graham's case
4. Biogen v. Medeva.
5. Kirin-Amgen Inc. v. Roche Diagnostics GmbH
6. KSR Intl' Co. v. Teleflex Inc.31 the United States Supreme Court
7. Dimminaco A.G v. Controller of patent and design,
CHAPTER 1
1.1 INTRODUCTION
1.2 DEFINITION AND MEANING OF BIOTECHNOLOGY
1.3 HISTORICAL DEVELOPMENT OF BIOTECHNOLOGY
1.4 PATENTABLITY OF BIOTECHNOLOGY INVENTIONS
CHAPTER 2
2.1 INTERNATIONAL STANDARDS AND POLICY ISSUES
2.2 INTERNATIONAL TREATIES
CHAPTER 3
3.1POSISITION IN USA
3.2 EVOLUTION OF BIOTECHNOLOGY IN US
3.3 PATENTING OF PLANTS
3.4 PATENTING OF ANIMALS
3.5 PATENTING OF MICRO ORGANISMS
3.6 PATENTING OF HUMAN CELLS AND GENETIC MATERIAL
3.7 PATENTING OF FRAGMENTS OF DNA AND GENES
3.8 PATENTING OF BIOTECHNOLOGY PROCESSES AND METHOS
3.9 ISSUES
CHAPTER 4
4.1 POSISTION IN EUROPEAN UNION
4.2 EVOLUTION OF BIOTECNOLOGY IN EUROPEAN UNION
4.3 PATENTING OF PLANTS
4.4 PATENTING OF ANIMALS
4.5 PATENTING OF MICRO ORGANISMS
4.6 PATENTING OF HUMAN CELL AND GENETIC MATERIAL
4.7 ISSUES
CHAPTER 5
5.1 POSISITION IN INDIA
5.2 EVOLUTION OF BIOTECHNOLOGY IN INDIA
5.3 PATENTABLITY SUBJECT MATTER IN INDIA
5.4 PATENTING OF MICRO ORGANISMS
5.5 PATENTING OF HUMAN CELLS AND GENETIC MATERIAL
CHAPTER 6
6.1COMAPARATIVE STUDY IN USA,EUROPEAN UNION AND INDIA
6.1. USA
6.2. EUROPEAN UNION
6.3.INDIA
CHAPTER 7
7.1 CONCLUSION AND SUGGESTIONS
7.2 BIBLIOGRAPHY
7.3 WEBLIOGRAPHY
CHAPTER 1
1.1 INTRODUCTION
The term ‘biotechnology’ is a combination of two words ‘bios’, which
means life. ‘Technology’ means application of scientific knowledge for
practical purposes to get desired results. Biotechnology means the scientific
knowledge that uses life or living entities like micro-organisms, plants, and
animals for practical and commercial purposes to get desired results.
Biotechnology is defined in numerous ways in different terms however there
is no universally accepted definition. Biotechnology is very dynamic and
progressing rapidly therefore, it is not possible to define biotechnology- in
exact terms. There are many definitions of biotechnology and yet there is
more confusion as to what it is and what is involved in the practical activity.
Many organizations and working parties have published reports where an
attempt has been made to define biotechnology. The United Nations congress
office of technology assessment defines biotechnology to mean any technique
that uses living organisms to make or modify a product to improve plants or
animals or to develop micro-organisms for specific uses. The European
Federation of Biotechnology (EFB) considers biotechnology as the integration
of natural sciences and organisms, cells, parts thereof, and molecular
analogues for products and services. British biotechnologists define
biotechnology as an application of biological organisms system or processes
to manufacturing and service industries. Japanese biotechnologists define
biotechnology to means a technology using biological phenomena for copying
and manufacturing various kinds of useful substances.
1.2 DEFINITION AND MEANING OF BIOTECHNOLOGY
The term ‘biotechnology’ is a combination of two words ‘bios’, which means
life. ‘Technology’ means application of scientific knowledge for practical
purposes to get desired results. Biotechnology means the scientific knowledge
that uses life or living entities like micro-organisms, plants, and animals for
practical and commercial purposes to get desired results. Biotechnology is
defined in numerous ways in different terms however there is no universally
accepted definition. Biotechnology is very dynamic and progressing rapidly
therefore, it is not possible to define biotechnology- in exact terms. There are
many definitions of biotechnology and yet there is more confusion as to what
it is and what is involved in the practical activity. Many organizations and
working parties have published reports where an attempt has been made to
define biotechnology. The United Nations congress office of technology
assessment defines biotechnology to mean any technique that uses living
organisms to make or modify a product to improve plants or animals or to
develop micro-organisms for specific uses. The European Federation of
Biotechnology (EFB) considers biotechnology as the integration of natural
sciences and organisms, cells, parts thereof, and molecular analogues for
products and services. British biotechnologists define biotechnology as an
application of biological organisms system or processes to manufacturing and
service industries. Japanese biotechnologists define biotechnology to means a
technology using biological phenomena for copying and manufacturing
various kinds of useful substances.
However, biotechnology is broadly defined as any technique that uses living
organisms or parts of organisms to make or modify product to improve plants
or animals or to develop micro- organisms for specific uses. It is not a single
technique but a combination of different techniques used to manipulate living
organisms in directed fashions. Perhaps biotechnology is multi-disciplinary in
nature, a series of advanced technologies spanning biology, chemistry, bio-
chemistry, micro-biology protein engineering, process engineering, and
genetic engineering put together and collectively called as biotechnology in
other words biotechnology means the application of technology or scientific
knowledge to the biological process. It involves human intervention to the
natural biological process by way of technical contribution to arrive at desire
results therefore biotechnology is an application of human invented
techniques to natural biological process. The invention biotechnology or
called biotechnological invention is define to means, any invention which is a
product consisting or containing biological materials or process by means of
which biological material is produced, process or used.
1.3 HISTORICAL DEVELOPMENT OF BIO-TECHNOLOGY
In 1919 Karl Erkay, a Hungarian engineer, coined the term bio-technology. At
that time the term biotechnology encompassed the production of desired
goods from raw materials with the aid of living organisms. Basically,
biotechnology is a study relating to the application of technology to living
organisms or their components. Historically, biotechnology was an art,
involved in the production of wine, beer, and cheeses. Today, it involves a
series of advanced technologies spanning biology, chemistry, biochemistry,
microbiology, protein engineering, process engineering, and genetic
engineering. In recent years innovations involving genetic engineering have
had a major impact on biotechnology. The story of the use of biological
systems for the fulfillment of human needs perhaps started in 6000 BC. In
fact, biotechnology can be traced back to approximately 6000 BC when
Sumerians and Babylonians first used yeast to make beer. Egyptians were
baking leavened bred by 40000 BC and in China fermentation processes were
discovered for preserving milk by lactic acid bacteria to make yogurt to
produce cheeses. Beginning with fermentative use of biological processes,
many changes experienced over the centuries. Modern biotechnology can be
traced back to the eighteenth century when smallpox was cultured to invoke
an immune response and prevent development of more serious diseases later
in life. During the eighteenth century cross-fertilization was discovered and
crop rotation was practiced to increase yield. The process of sterilization was
also discovered during the eighteenth century.
In the nineteenth century, Louis Pasteur, known as the father of
biotechnology, demonstrated fermentative ability of micro-organisms. During
that time epidemiological observations were used to develop the hypothesis of
cross-infection by spread of childbirth fever from mother to mother by
physicians, which led to the practice that physicians wash their hands after
examining each patient. Another milestone during the nineteenth century was
the invention of a process of beer fermentation by Louis Pasteur in 1873. He
proved that microbes were responsible for fermentation. He also invented the
pasteurization process, which involves heating wine sufficiently to deactivate
microbes. In the 1940s complicated techniques were introduced for mass
cultivation of micro-organisms to exclude contaminated micro-organisms. In
fact, Gregor Mendel’s presentation of the law of heredity, development of
Pasteur’s rabies vaccine, discovery of chromosomes, discovery of the
protozoan plasmodium as a cause of malaria, and the investigation of anthrax
were all milestones in the development of biotechnology.
But the greatest revolution took place in the 1970s and 1980s when product of
interaction between the science of biology and technology came into wider
existence and the relationship got the name biotechnology. Modern
biotechnology has got its roots in the early 1980s when recombinant DNA
technology or genetic engineering developed modern biotechnology is more
concerned with genetic engineering. Commercial production of human insulin
through recombinant DNA technology in the United States showcased the
potential of recombinant DNA technology. The development of process
engineering and protein engineering that involves methods of protein
production through recombinant DNA technology adds another feather to the
wings of modern biotechnology. The development of biotechnology can be
classified into three generations.
First generation of biotechnology
The first generation of biotechnology is based on empirical practice and
minimal scientific or technical inputs. These techniques date back to the Stone
Age and involve using of biological organisms such as bacteria, yeasts,
enzymes, and traditional methods of fermentation to produce food and drink
such as bread and wine. Production of cheese and beer by using micro-
organisms was the milestone of this generation.
Second generation of biotechnology
This generation began during the interwar period when developments in
fermentation technology using pure cell culture and sterile manufacturing
facilities began to yield new products. During this generation innovations such
as acetone, butanol, glycerol, vitamin B2, citric acid, and lactic acid took
place. The invention of penicillin in 1928 was the milestone of the second
generation.
Third generation of biotechnology
Three important technologies, namely, tissue cell culture, Hybridoma
technology, and recombinant DNA technology also known as genetic
engineering were developed in the third generation. These three technologies
represent modern biotechnology. Tissue culture technology is used to
establish cell lines, which are used for medical diagnosis and treatments.
Hybridoma technology is used in the production of human monoclonal
antibodies, which are used to supplement natural human antibodies in medical
treatments.
The invention of DNA by Crick and Watson in 1953 was the turning point in
the third generation of biotechnology. The recombinant DNA technology is
the technique that involves manipulation of genetic materials of a living being
to get desired results. Indeed it is recombinant DNA technology which
brought biotechnology into limelight. Modern biotechnology is defined on the
basis of genetic engineering. The inventions of biotechnology are playing a
vital role in the industrial sector. Most of the biotechnology inventions fall in
the sphere of food, agriculture, and medical industry. Certain inventions of
biotechnology fall in the sphere of forestry, environment, energy, and
chemistry.
Biotechnology is an inter-disciplinary pursuit and it is multi-disciplinary in its
application. The term multidisciplinary describes a quantitative extension of
approaches to problems that commonly occur within a given area. Recently a
characteristic feature of the development of science and technology has been
the increasing resort to multidisciplinary strategies for the solution of various
problems. One such idea of multidisciplinary pursuit has resulted in the
crystallization of a new discipline called biotechnology. Being
multidisciplinary, biotechnology involves the marshalling of concepts and
methodologies from a number of separate disciplines and applying them to a
specific problem in another area. Besides, biotechnology has diverse
application in different fields. The successful application of biotechnology
depends upon the cooperation of the experts in different fields. The scope and
application of biotechnology is increasing day-by-day. Earlier biotechnology
was limited to fermentation of beer, but today it is significant in
revolutionizing certain areas of industry such as agriculture, animal
husbandry, medical and pharmaceutical industry, forestry, fisheries,
environmental protection, chemical industries, food, beverages, and many
others. In order to understand the scope and significance of biotechnology it
would be proper to discuss its application in different fields.
Agriculture and biotechnology
Agriculture is a sector which feeds the hungry of the world. The produce of
the sector is used at least twice or thrice a day by everyone. For many
economies including India agriculture sector is the backbone. The demand for
high production in the sector is increasing day-by-day, as there is increase in
the population. In order to meet the demand of the increasing population, there
should be increased production. Further, directly or indirectly, the industrial
sector also depends on the agriculture sector for raw material. Therefore,
demand for increased production in the agriculture sector is very much felt. In
ancient times agriculturists were practicing different methods to increase
production, e.g., changing crop in order to avoid continuous cropping of the
same crop, crossing, budding, grafting, and tissue culture. However,
application of biotechnology in the agricultural sector is giving rise to
revolutionary changes in the filed promising to yield good results. Today in
the era of biotechnology these traditional methods have been replaced by
methods such as genetic engineering, yielding the best results.
There are many plants that grow withstanding water shortages and a few
plants that resist pests and weeds. Further, there are plants that give high yield.
How would it be if plants in drought areas could grow with minimum use of
water. How would it be if regular crops could show resistance to pests and
weeds? How would it be if regular crops could give higher yield? It is just not
an imagination but very much in the realm of possibility through
biotechnology. Biotechnology through genetic engineering, a willow in its
armoury, is promising to produce such super crops with desired qualities. Any
crop or plant could be engineered for desired results. By manipulating the
genome of plants, genes coding for certain features like resistance to pests,
weeds, herbicides, and tolerance to drought conditions, high-yielding genes
could be isolated and incorporated into an intended crop. This technique of
isolating and incorporating genes is called genetic engineering. It involves
marshalling of genes to manifest characteristic features of plants in order to
get better and improved crops bestowed with desired characteristics.
This technique of marshalling genes birth to genetically engineered plants
with qualities such as high yield, capacity to result pests, insects and weeds
and also capacity to withstand drought conditions. If an engineered plant gives
higher yield that the regular plant at the same cost of production, it will
definitely benefit the farmer as well as the society. Further, a plant that is
resistant to insects, weeds, pests, and herbicides will reduce the cost of
production. It is estimated that 20 to 40 per cent of the world’s agricultural
production is lost due to pests, weeds and diseases and additional 40 per cent
would suffer the same fate without pesticides application. The global estimate
of loss due to plant diseases in 1987 was approximately US $ 90 billion.
Therefore, biotechnology, capable of producing crops that are featured to
result viruses, pests, and weeds, plays a vital role in modern-day agriculture.
In the developed countries the impact and application of biotechnology in the
agriculture sector is highly felt. In the United States of America fifteen
transgenic plants were given market permission in 1995. Another thirteen
plants were awaiting permission. In Europe reportedly 496 transgenic plants
were released during 1986-94. Slowly but gradually, the developing world is
caching up with the developed world. In India some field trials of transgenic
plants were conducted during 1995-96. A few multinational companies, active
in the agriculture sector, have tie-ups with Indian companies like Proagro
Seed and Mahyco Seed. In fact, Mahyco Seed Company is conducting trials
on imported BT cotton in India. Recently, Novavax, an American biotech
company, tied up with Bharath Biotech Company based in Hyderabad. Many
multinational companies are showing interest in tie-ups with Indian
companies and are intending to open their branches in India. It is a healthy
sign for the development of biotechnology in India. Application of
biotechnology has increased production levels and decreased the cost of
production. biotechnology produce engineered crops like BT cotton, BT rice,
BT soybeans, BT wheat, BT tomato, and BT potato. Compared to regular
crops, genetically engineered wheat and rice are said to yield up to 30 per cent
more under same cultivation conditions. It is evident that genetically
engineered plants are capable of giving better quality, higher yield, and
resisting pests and weeds. Therefore, the application of biotechnology in the
sector is yielding fruitful results.
Animal husbandry and biotechnology
In the field of animal husbandry application of biotechnology tends of
produce high yield of milk, and wool. Biotechnology is being applied in the
animal husbandry through tissue culture, cloning, and genetic engineering.
Tissue culture involves isolating and culturing of cells or organ of an animal
in vitro (outside the body) for a desired result. Tissue culture in animals is
useful in testing drugs and medicines. Cloning involves developing the replica
of a living being through isolating some tissue or cell of the original living
being and developing the same into a complete living being which resembles
the original. Dolly, the most popular sheep in the world, to a sequel of
cloning. Genetic engineering of animal involves isolation of specific genes
coding for certain characteristics and incorporation and expression of the same
in an intended animal to get desired results. We have seen hybrid animals
produced through crossing of two different animals with different genetic set
up. Crossing a disease-resisting animal with a high milk yielding animal may
result in offsprings possessing both the desired qualities of disease resistance
and high milk yield. Now genetic engineering is proving even more useful to
get desired results in animal husbandry.
A few animals resist diseases but are incapable of giving high yield of
mil, flesh or wool, whereas animals that give high yield of milk, flesh or wool
but are incapable of resisting diseases. How would it be like if the same
animal possesses both the features, viz. resisting diseases and giving high
yield as well. Genetic engineering, a sub-discipline of biotechnology,
promises to materialize such a dream in animal husbandry. Genetic
engineering made it possible to isolate the genes coding for specific
characteristics from different animals and to incorporate the same into an
intended animal. For example, gene coding for high yield can be isolated and
incorporated into an animal possessing both the characteristics. Through this
technique genetically engineered sheep capable of giving high yield of flesh
and wool, genetically engineered cow capable of giving high yield of milk
were produced. Further cow’s milk cab be enriched with high protein values
by incorporating a particular gene coding for such specific protein into its
body. Likewise, flesh of sheep can also be enriched with high protein values.
Similarly, through marshalling of genes it may be possible to produce
genetically engineered monkey, rabbit, or a mouse.
Besides, genetically engineered animals are used in testing drugs,
medicines, and therapies. It is a regular practice in the medical filed to test
drugs or medicines or therapies on animals before conducting their trials on
human. Sometimes genetically engineered animals are produced solely for the
purpose of testing drugs and medicines. Once-mouse is one such example
where it is produced with sole objective of testing cancer disease. Further
certain proteins, antibodies, and enzymes produced inside the body of
different animals have medicinal values. Such proteins, if produced
commercially, can be used for preparing drugs and medicines. Perhaps the
body of pig is known as the pharmaceutical factory. It produces many proteins
and antibodies inside its body, which have got significant medicinal values.
Biotechnology promises commercial production of such proteins through
isolation and incorporation of the specific gene coding for such protein into an
intended organism. Such genetically engineered organism produces the
desired protein in its body.
1.4 Patentability of Biotechnology Inventions
Inventions are patented on the basis of certain criteria. It is universally
recognized that an invention must satisfy a few requirements such as novelty,
non-obviousness, and industrial applications and written description before a
patent is granted. It is important to note that the three universally recognized
criteria of patentability, namely, novelty, non-obviousness, and industrial
applicability or utility applies to all inventions including biotechnological
inventions.1 However, patenting of life or living beings produced through
biotechnology commands special attention due to inherent complexities of the
nature of biotechnology inventions. Difficulty is felt in patenting a living
being mainly due to the following three reasons:
1. It is doubtful whether patent protection will be granted to living matters.
2. Biotechnology inventions are difficult to describe.
3. How to consider biotechnological new findings: as inventions or as
discoveries.
It is felt that the requirements of the traditional patent law are not
enough to test the patentability of biotechnological inventions. In case of
biotechnological inventions it is quiet difficult to differentiate between an
invention and a discovery. Since biotechnological inventions involve living
beings, it requires special attention before a patent is granted. Due to the
inherent complexities and technicalities, sometimes biotechnological
inventions cannot be described in the written specification. To overcome this
problem a solution was evolved in the form of deposit of the invention in any
recognized depositories.3 The Budapest treaty recognizes international
depositories where inventions related to living matter can be deposited and
maintained for the purpose of patent protection.4 The deposit of the invention
enables the patent examiner to test the genuineness of the invention before Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries, New
Delhi : Oxford University Press, First published 2001, Third impression 2002, p. 132.
M.S. Swaminathan. An Introduction to the Guiding Principles in the Decisions on Patent
Law, Delhi: Bahri Brothers, 2000, p. 331.. Budapest treaty, 1977, provides for the establishmenand
recognition of international
depositories to deposit inventions of life forms and other biotechnological inventions for
the grant of patent along with the patent application.
Budapest treaty was signed and done at Budapest, in 1977. Any member of the Paris
Convention may become party as per Article 15 of the treaty. See, Manish Arora, Guide to
Patent Law, Delhi : Universal Publishing Co., 2000, p. 410.
the grant of a patent. It is recommended that in case of claiming
biotechnological inventions for patents, the deposit of the invention shall
accompany the patent application. Therefore, a biotechnological invention
must satisfy the requirement of deposit of the invention along with the usual
patentability requirements. Hence, it is inferred that patentability of
biotechnological inventions depends on satisfying the regular requirements
under the patent laws along with the deposit of the invention. The essential
requirements that a biotechnological invention or an invention involving
living beings must meet the following criteria to be eligible for patents:
Patentable subject matter.
Novelty
Non-obviousness (inventive step).
Industrially applicable (utility).
Written description of disclosure of the invention and the deposit of the
invention
PATENTABLE SUBJECT MATTER
The first and foremost requirement is that an invention should fall within the
ambit of patentable subject matter. Inventions falling within the purview of
patentable subject matter are only eligible for patent protection. The
components of patentable subject matter were not initially uniform in different
countries. However, with the coming into being of TRIPS, there is uniformity
in bringing inventions within the scope of patentable subject matter in broad
terms. It states that patents shall be made available for any invention, whether
products or process, in all fields of technology provided that they are new,
involve an inventive step, and are capable of industrial application. It further
states that patents shall be available without discrimination as to the place of
invention, the field of technology, and whether the products are imported or
locally produced.6 However, members states of the TRIPS agreement may
exclude from patentability inventions, including inventions of life forms of
biotechnology, on grounds of public order, morality, protection of human,
animal or plant life, or health, or to avoid serious prejudice to the
environment. Members states may also exclude from patentability and also
diagnostic, therapeutic and surgical methods for the treatment of humans or
animals; plants and animals and essentially biological processes for the
production of plants or animals. However, it is believed that micro-
organisms, plants, and animals produced through non-biological or
microbiological processes could be patented under the agreement. Therefore,
it is inferred that biotechnological inventions resulting out of biotechnological
processes, which do not come within the meaning of essentially biological
processes, are patentable.
Article 27 of the TRIPS agreement.
The TRIPS agreement Article 27, sub-clauses (2) and (3).
Invention v. Discovery
It is universally accepted that patents are given for inventions and not for
discoveries. It has long been established that discoveries are not patentable.
Invention is something newly designed or created or the activity of designing
or creating new things. Discovery is the act of finding something that had not
been known before. The term invention is not defined under TRIPS or under
other international conventions on patents like the Paris convention or the
Patent cooperation treaty. Even the recent European directive on
biotechnological invention does not define the term invention. The US patent
statute defines the term invention to mean any invention or discovery. As per
the US patent law, there is no difference between an invention and discovery.
However, discovery amounts to the finding of a thing that is existing in the
nature but not known before, whereas invention means creation of design of
something totally new that was not there before.
The philosophy of patent law states that inventions can be living things.
At the same time discoveries can also be living things. It is believed that
discovery of living beings existing in nature is not patentable but inventions of
new living beings that do not exist in nature are patentable. It is felt that a
discovery does not involve creation or design of new thing, hence, it is not
patentable. Almost all patent laws throughout the world say that discoveries of
substances found in nature do not constitute an invention and are excludable
from the grant of patent. Strictly speaking, inventions of biotechnology are not
totally new but are manipulated living beings found in nature. Therefore, there
is a need to draw a distinguishing line between a discovery and an invention in
the light of patenting products of biotechnology. The very first objection
against patenting of living beings is that living beings are discoveries or
products of nature existing and found in nature. In fact, biotechnological
inventions are based on products foundin nature.
The starting point or raw material for these inventions is biological
material found in nature. It is believed that finding of biological things
existing in nature amounts to discovery. It is also believed that the
manipulation of pre-existing biological resources in nature gives rise to
biotechnological inventions. Perhaps human intervention makes a product of
biotechnology different from a natural biological product. Human intervention
to the biological resources yields new, non-natural, man-made, and hitherto
not existing living beings. Here the distinction between a pre- existing
biological product and a human-intervened, human-made, biotechnological
product is very thin. The distinction relevant to patentability, between the
‘discovery’ of something that exists in nature and the invention and creation
of something new, involving a predetermined degree of human effort, or
invention is, in practice, difficult to make in the field of biotechnology. One
of the contentious issues raised on aspect of biotechnological inventions is
that of the extent to which the traditional concept of invention can be applied
to protect these inventions.
Biotechnology is notable for designing or creating new things that were
not existing hithesto. Biotechnological inventions are the sequal of human
ingenuity and intellect to the existing natural resources. Finding of biological
things in nature amounts to discovery. However, adding human ingenuity to
such biological things gives rise to an invention. Therefore, till the addition of
human ingenuity a biological product remains a discovery and the application
of the human ingenuity thereafter makes it an invention. However, the
complication arises due to the fact that it is becoming increasingly difficult to
determine where ‘discovery’ ends and ‘invention’ begins. This issue is
resolved more through judicial decisions and patent office practices on the
facts and circumstances of each case rather than through clear-cut criteria laid
down in law.
The case law pronouncements have made it clear that finding of a product of
nature is a discovery. A product of nature becomes a product of man due to
the intervention of human being or due to the application of human ingenuity.
It is to say that, a product of nature through some human intervention becomes
product of man. This human intervention to the product of nature gives it a
new existence, making it possess some special features which it did not have
earlier, thus making it an invention. On the whole it creates a new living entity
with some special characteristic features, which were not in existence earlier.
Therefore, product of nature through some human intervention becomes a
product of man, which does amount to an invention. On the same lines the
process of isolating living entities from its natural surroundings in purified
form is patentable. Further, the result of such a process, the natural living
entities in the isolated and purified form, are also
patentable.
All unicellular organisms with dimensions beneath the limits of vision, which can be
propagated and manipulated in a laboratory, are termed as micro-organisms. Micro-
organism includes bacteria and yeasts as also fungi, algae, protozoa, plasmids, viruses.
P.K. Vasudeva, Patenting Biotech Products: Complex Issues EPW Commentary, 14-20
October, 2000.
Cambridge Dictionary of American English, Cambridge : Cambridge University Press, 2000.
Paris convention for the protection of industrial property, 1983, as amended in 1979.
Patent cooperation treaty, 1970, modified in 1984
European directive on the legal protection of biotechnological inventions, 1998.
35. United States Patent Act, Section 100
Dr K.V. Swaminathan. An introduction to the Guiding Principles in the Decisions on Patent
Law, Delhi : Bahri Brothers, p. 224.
A mere discovery of something that exists in nature, forming part of the state of the art
(prior art) is not patentable.
Dr T. Ramakrishna, Biotechnology and Intellectual Property Rights, Bangalore : Centre for
Intellectual Property Rights Research and Advocacy (CIPRA), National Law School of India
University, 2003.
CHAPTER 3
2.1 INTERNATIONAL STANDARDS AND POLICY ISSUES
1. AGREEMENT ON TRADE-RELATED ASPECTS OF
INTELLECTUAL PROPERTY RIGHTS
PART II STANDARDS CONCERNING THE AVAILABILITY, SCOPE AND USE OF
INTELLECTUAL PROPERTY RIGHTS
Section 4.PatentsSECTION 5: PATENTS
Article 27
Patentable Subject Matter
1. Subject to the provisions of paragraphs 2 and 3, patents shall be
available for any inventions, whether products or processes, in all fields
of technology, provided that they are new, involve an inventive step and
are capable of industrial application.5 Subject to paragraph 4 of Article
65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents
shall be available and patent rights enjoyable without discrimination as
to the place of invention, the field of technology and whether products
are imported or locally produced
2. Members may exclude from patentability inventions, the prevention
within their territory of the commercial exploitation of which is
necessary to protect ordre public or morality, including to protect
human, animal or plant life or health or to avoid serious prejudice to the
environment, provided that such exclusion is not made merely because
the exploitation is prohibited by their law.
3. Members may also exclude from patentability:
(a) diagnostic, therapeutic and surgical methods for the treatment of
humans or animals;
(b) plants and animals other than micro-organisms, and essentially biological
processes for the production of plants or animals other than non-biological
and microbiological processes. However, Members shall provide for the
protection of plant varieties either by patents or by an effective sui generis
system or by any combination thereof. The provisions of this subparagraph
shall be reviewed four years after the date of entry into force of the WTO
Agreement.
2.2 INTERNATIONAL TREATIES
CHAPTER 3
3.1POSISITION IN US
3.1.1 Patentable subject matter in the United States
The United States Patent Act, 1952 states that any invention of new and useful
process, machine, manufacture, or composition of matter, or any new and
useful improvement thereof may constitute patentable subject matter. The
United States patent law expressly does not state what constitutes patentable
subject matter and what does not. It outlines broad scope of subject matter that
is patentable. Accordingly, the threshold inquiry of all patent applications is
whether the claimed invention can be classified within this range. Any subject
matter that falls within the prescribed range is patentable. It implies that the
patentable subject matter includes any method of manufacture, machine,
composition of matter, or process.
The United States patent law does not say anything specifically about
biotechnological inventions involving life. However, the US judiciary has
interpreted the patentable subject matter under the patent law to cover living
beings. In Diamond v. Chakraburty for the first time US Supreme Court was
confronted with a question whether the patentable subject matter under the US
patent law does cover living beings or not? The invention claimed was a
genetically engineered micro-organism. The inventor contended that the
invention is a patentable subject matter as it is a composition of matter. The
US Supreme Court liberally interpreted the term ‘composition of matter’ to
include living beings also. It was held that living beings are patentable, as the
patent law does not prohibit the same. It was observed that living beings
produced through biotechnology involve re-composition of physical and
chemical properties and hence are composition of matter within the meaning
of patentable subject matter under the patent law. After this decision patent
offices throughout the world started issuing patents on living beings produced
through biotechnology by considering them as a composition of matter within
the scope of patentable subject matter.
The decision of the Supreme Court was a trend-setting decision in the
annals of patent law as it interpreted the patentable subject matter to include
living beings produced through biotechnology. After the decision, patentable
subject matter under the US patent law now covers living beings also. As
biotechnological inventions are concerned with life or living beings the
decision had far reaching impact on biotechnological inventions. In later
decisions, the US Supreme Court and as well as the US patent office
interpreted patentable subject matter to include living beings such as plants,
animals and human genetic material. In Ex Parte Hibberd a plant was held to
constitute patentable subject matter. In Harward on co-mouse it was decided
that a genetically engineered animal does constitute patentable subject matter.
In Amgen Inc. v. Chugai Pharmaceuticals Co., human genetic material like
DNA was held to form patentable subject matter. Again in re Bell human
DNA was held to constitute a patentable subject matter.
Further, human cloning methods were also held to constitute patentable
subject matter. In all the above decisions the expression ‘composition of
matter’ was interpreted to cover living beings, within the meaning of
patentable subject matter. It is inferred that biotechnology processes and
biotechnology products like microorganisms, plants, animals, and human
genetic materials do constitute patentable subject matter in the United States
and are patentable. However, it is believed that human being does not
constitute a patentable subject matter under the US patent law, since cloning
of human is punishable under the Human Cloning Prohibition Act. It is
believed that human beings do not constitute a patentable subject matter.
US Patent Act, 1952, Section 101 Inventions patentable.
(1980) USSC 447 at 303.
Ex Parte Hibberd, See Jayashree Watal, Intellectual Property Rights in the WTO Countries,
Oxford University Press, First Published in India, 2001, Third impression, pp. 178-87.
Harward Onco-mouse decision in 1988.
Amgen Inc. v. Chugai Pharmaceuticals Co. Ltd 927 F.2d 1200.18 USPQ 2d 1016 (Fed.Cir.1991).
3.2 EVOLUTION OF BIOTECHNOLOGY IN US
In the United States, Thomas Jefferson drafted the first patent statute which
was enacted in the year 1793. The Act articulated the requirements of
patentability as enshrined under the Venetian statute such as ‘utility’,
‘novelty’, and ‘non-obviousness’. The philosophy behind the 1793 Act was
that ‘the ingenuity should receive a liberal encouragement’ The Act defines
patentable subject matter in broad terms to mean ‘any new or useful art,
machine, manufacture or composition of matter, or any new or useful
improvement thereof’. The subsequent Acts of 1836,1870, and 1874 reiterate
the philosophy outlined by the 1793 Act. In the year 1952 the law on patents
was recodified in the form of Patents Act, 1952. In doing so, the term art was
replaced with process in the definition of the patentable subject matter. The
altered definition of patentable subject matter stands as ‘any new and useful
process, machine, manufacture or composition of matter or any new and
useful improvement thereof.’ In all these enactments on patents, living
organisms were kept out. This was not due to any religious belief or ethical
consideration, but due to the fact that living organisms were considered to be
the ‘common heritage’ of mankind and not considered to be patentable
3.2.1History and evolution of biotechnology patent law
The evolution of biotechnology patent law can be traced back to the United
States. The United States Constitution states the Congress shall have the
power to promote the progress of science and useful arts, by securing for
limited times to authors and inventors the exclusive right to their respective
writings and discoveries. The plain meaning of the above provision does not
say anything about patenting of biotechnology. It merely signifies Congress’
power to promote the progress of science and arts by granting exclusive rights
to the inventors for a limited time. The promotion of science is the threshold
of Patent Law. The United States Patent Act in its original form does not say
anything about patenting of biotechnology inventions. It states that whoever
invents or discovers any new and useful process, machine, manufacture, or
composition of matter or any new and useful improvement thereof, may
obtain a patent there for, subject to the conditions and requirements under the
patent law. As in the Venetian statute, so also in the 1952 patent law living
beings are not considered patentable subject matter. The recent emergence of
the science of biotechnology made it possible to invent new and innovative
living beings. However, these developments of biotechnology were not
expected and no provision was made in the then existing patent laws. Before
the biotechnology era, patenting of living beings was out of all purviews. But
it was the judiciary that took initiative to interpret the existing patent law in an
innovative and liberal way, to offer patent protection to biotechnology
inventions. In fact, more than legislative initiatives, judiciary’s
pronouncements have laid the foundation for the evolution of biotechnology
patent law. The judiciary did not alter or change any provisions of existing
patent law; rather it has taken a liberal approach in interpreting patent law.
Today, biotechnological inventions do constitute patentable subject matter to
the credit of judiciary for its liberal and innovative interpretation of patent
laws. Earlier in the nineteenth century, there were moves to patent living
process in the United States. For the first time the United States Patent Office
granted a patent to Louis Pasteur on ‘yeast’ that is free from organic germs of
disease. It was the first incidence in the history of patent law wherein a patent
was granted on a living matter. The Patent Office considered the invention as
an article of manufacture within the meaning of patentable subject matter
under the US patent law, but the fact that the invention claimed was a living
process was not taken into account. Patent was indeed granted on a living
matter but the approach was not in favour of granting patents on living matter
or living processes. Subsequently in Exparte Latimer a patent claim for fibre
found in the
needle of the Pinus astralis was rejected. The belief was that plants, even those
artificially bred, were products of nature for purposes of the patent law. A
general principle was set that plants were natural products and not subjected to
patent protection. The view taken was that patent on such fibre would lead to
patents on the trees of the forest and the plants of the earth, which was
considered unreasonable. Besides, it was thought that it was not possible to
describe plants in a written form, as new plants might differ from old in colour
and perfume that cannot be described in a written form. Hence it was decided
that plants could not satisfy written description requirement under Section 112
of the United Sates patent statute. The case law has postulated the following
two principles
1.Plants are products of nature though artificially bred, and are not patentable.
2. Plants are not amenable to the ‘written description requirement’ of the
patent law.
The above two principles were found to be hurdles for granting patent
protection for plants. Since 1930 living organisms were not considered as
patentable. However, the Plant Patents Act, 1930, relaxed the situation by
providing that the work of plant breeder in aid of nature was patentable
invention. The Act extended patent protection to certain asexually reproduced
plants, such as reproduction of plants by grafting and budding. The Act was
viewed as reflecting the legislative attention to the problems of patenting
living organisms. The Act has also relaxed the requirement of written
description by stating that reasonable written description is enough to grant
patents. The purpose of the Act was to solve the technical problem of
description of plants referred to in the Latimer decision (no. 10 supra). In
1970 Congress enacted the Plant Variety Protection Act, 1970, which
extended protection to certain new plant varieties capable of sexual
reproduction. It seems Congress intended to promote the agricultural industry
by encouraging patents on asexually reproduced plants.
The 1930 Act as well as 1970 Act did not show any indication of including
bacteria within the purview of the patentable subject matter. These Acts
strongly evidence a congressional limitation that excludes bacteria from
patentability. The issue of including bacteria within the purview of patent
protection was considered at the time of passing of the 1970 Act but the same
did not materialize. Soon after the passage of the Plant Patent Act,
1930, US courts decided whether certain living things form part of the
patentable subject matter or not. An opportunity arose for the courts to
interpret the patentable subject matter under Section 101 of the patent statute.
As per the language of the patent statute patentable subject matter
encompasses any ‘new and useful process, machine, manufacture or
composition of matter or any new and useful improvement thereof.
The term ‘manufacture’ was interpreted in American Fruit Growers Inc v.
Brogdex Co. The claims were for ‘coated oranges’. It was considered whether
the claimed invention comes within the meaning of the term ‘manufacture’.
The court happened to interpret the term ‘manufacture’ to mean the products
of articles for use from raw or prepared materials by giving to these materials
new forms, qualities, properties, or combinations whether by manual labour or
by machinery. The term ‘manufacture’ implies the production of new articles
by using raw materials and giving such raw materials a new form, quality, and
properties or a combination of these. In the instant case the
court rejected the claims on the ground that coated oranges were not
sufficiently modified. The court held that the claimed oranges were not
attributed considerably new qualities, properties, or a combination of these in
order to be considered as a manufacture. The decision of the court lays down
that the inventors would have got the patent if their claimed oranges were
considerably modified to posses, new qualities, properties or their
combination. It seems that in the early part of the twentieth century itself
America was inching towards patenting of living beings. However, existing
living organisms or biological resources were used as raw materials in
producing biotechnology inventions. The living being was the manipulation
and manifestation of an existing living being giving it a new look or features,
which it was not. Such being the case, it can be inferred that biotechnological
inventions do come within the meaning of the term ‘manufacture’ forming
part of the patentable subject matter.
3.3 PATENTING OF PLANTS
Patenting of Plant-related inventions
In the US, there are three forms of protection for plant-related inventions.
These are Utility Patents, Plant Patent Act (PPA), Plant Variety Protection Act
(PVPA). The utility patents and the plant protection patents are granted by
USPTO while the PVPA is granted by Plant Variety protection Office
governed by USDA. Utility patents awarded in the US cover conventionally
bred varieties or genetically modified plants. A number of examples of utility
patents have been give in the later sections.
Plant patent is a right granted by the government to an inventor who has
invented or discovered and asexually reproduced new plant variety other than
tuber-propagated plant or plant found in uncultivated state. This grant lasts for
20 years (in the US) from the date of filing the application, protects the
inventor’s right to exclude others from asexually reproducing, selling or using
the plant so reproduced. This protection is limited to one plant variety. A sport
or mutant of a patented plant is not considered to have same genotype as that
of the parent plant. Hence, such plants are separately patented instead of being
covered by the plant patent of the parent plant.
The first plant patent was issued in 1931 to Henry Bosenberg of New
Brunswick, NJ, for a climbing or trailing rose. This invention was for
climbing roses bearing true blooming character. There was another plant
patent for a rose plant named ‘Breapum’ granted to Ezio Brea in 2003
(USPP14, 226 P3). The new and distinct cultivar had the unique
characteristics of long erect flowering stems, creamy white flowers and
orange hips arranged in sprays. A patent for Chrysanthemum plant named
‘Zembla’ (US PP14, 052 P2) was granted which was for an invention distinct
in possessing decorative inflorescence and possessing excellent post-
production longevity.
Tissue Culture Techniques and Genetic Transformation of
Plants
An important area of research in plants relates to tissue culture and genetic
engineering of plants. The intellectual property scenario on genetic
transformation of plants is quite complex. The subject matter considered
patentable under this category involves the following:
Transformation techniques: there are various transformation methods
basically classified into two categories, which permit introduction of genetic
material into plants to render them with properties like disease resistance,
improved seed quality, and insect resistance.
Agrobacterium-mediated transformation is an indirect method of
transformation that involves Agrobacterium tumefaciens, which is a common
soil bacterium that naturally inserts its genes into plants and uses the
machinery of plants to express those genes in the form of compounds that the
bacterium uses as nutrients. Agrobacterium-mediated transformation has been
dealt with in detail in Chapter 15, Section 15.12.1.
Patents related to transformation of dicot plant
US5, 024, 944 Transformation, somatic embryogenesis and whole
plant regeneration method for Glycine species
US5, 986, 181 Transformation and regeneration of fertile cotton plants
EP910239 Transformation of cotton explants with Agrobacterium
WO0042207 Transformation of a soybean germline with
Agrobacterium
Patents related to transformation of monocot plants
US6,720,488 Transgenic maize seed and method for controlling
insect pests
WO05096806 Edible vaccine in the form of rice
AU3402897 Transformation of wheat with Agrobacterium
AU7134298 Transformation of sorghum with
Agrobacterium/Pioneer Hi-Bred
There exists large number of patents where Agrobacterium has been
used for the transformation of dicotyledonous plants. Examples of some of
these patents are given in Table 22-4.
Transformation using Agrobacterium is now becoming popular among
the monocots. Some of the important patents that were granted in this regard
are listed below in Table 22-5.
Direct method of transformation, where direct uptake of the genetic
material by plant cell occurs (see Chapter 15, Section 15.12.2 for details) are
also in use. Some of the patents that use these techniques have been listed
below in Table 22.6.
Regeneration Protocols. For genetic transformation of plants an
excellent system of regeneration is necessary. There are many patents granted
for methods of regeneration using different explants such as leaves, roots,
hpyocotyls, cotyledons and seeds. A patent has been granted for a method for
regenerating cotton plant from explant tissue comprising regenerating
embroygenc callus from a cotton tissue explants cultivated on cotton initiation
media not supplied with exogenous plant hormones (EP910239B1 and US5,
846, 797).
Explants: The different types of explants that have granted patents are
listed below in Table 22-7.
Other patentable component: Transformation vectors, selectable marker
genes, reporter genes, promoters and enhancers are some of the important
components that are also patentable. A list of these that were used in golden
rice manufacture is given below in Table 22-8.
Genetically modified plant: Genes conferring resistance to insect pests and
various fungal, viral and bacterial disease have been successfully introduced
in variety of crop plants. Similarly, transgenic plants containing genes for
drought and salt tolerance, improved quality for value addition and increased
shelf life are produced through genetic transformation. The classic example is
of Bt transgenic plants into which the genes elaborating the insecticidal toxins
of Bacillus thuringiensis have been introduced. However, in India since plants
per se are not patentable, patents for genetically modified plants are not
allowed.
More than 400 patents have been granted on Bt isolates, strains, genes,
Bt toxin receptors and on specific proteins toxic to a given insect class or pest.
Bt toxin receptor BT R2 from Pectinophora gossypiella (pink bollworm) has
been patented (US6,645,497). A USBTS02618A, BTS02654B and
BTS02652E strains. Patents have been granted to polynucleotide
compositions encoding broad spectrum endotoxins (US6,645,497;
US6,538,109; US6,521,442; US6,448,226). Plasmid(s) containing
heterologous DNA coding for Bt crystal protein in E.coli is protected under
US patent (US4,467,036). A US patent (US6,326,169) disclose polynucleotide
compositions encoding Cry 1 Ac/Cry 1F chimeric endotoxins. Bt cry ETI
toxin gene and protein toxic to lepidopteran insect, Plutella xylostella
(Dimondback moth), has been patented (US5,356,623). This patent also
discloses the method of controlling susceptible lepidopteran insects by
applying the effective amount of insecticidal toxins to the host plant. A
European patent (EP0358557B1) discloses a new DNA sequence that encodes
the 130 kDa protoxin, the ‘Bt 18 protoxin’, from the genome of the B.
thruingiensis var. darmstadiensis HD -146. This protoxin cleaves into 62 kDa
of active toxin and is highly active against Lepidoptera species from the
Noctuidae family such as Spodopter species and Manducasxta. Five novel
nematocidal cry gene sequences are disclosed in European patent
(EP0462721). Two crylgene sequences are disclosed in European patent
(EP0401979).
Patents for modifying the Bt gene to optimize expression of the
insecticidal protein in plants have also been granted. A US patent
(US6,242,241) disclosed novel synthetically modified Bt chimeric crystal
protein having improved insecticidal activity against coleopteran, dipteran and
lepidopteran. This patent also covers nucleicacid encoding for these novel
peptide, methods of making and using these genes, and proteins, method for
the recombianant expression and transformation of suitable host cells,
transformed host cells, and transgenic plants expressing the said Bt toxin. Two
US patents (US6,033,874; US6,423,828) have been granted where novel
synthetically-modified B. thuringiensis cry 1C gene sequence encoding
endotoxins having lepidopteran-specific insecticidal activity has been
disclosed.
More than 482 patents had been filed or granted for inventions related
to Bt crops, some 95 of these patents involve transgenic plants. US patents
have been granted for the production of transgenic maize expressing the
synthetic Bt protein (US5,484,956; US6,720,488). US patent (US6,720,488)
discloses the method of production of transgenic maize expressing synthetic
Bt insecticidal crystal protein genes in which the codon usage has been altered
to increase expression of the Bt gene.
Patenting of transgenic plants
The impact of the decision on Chakraburty was such that it had not only
interpreted the patenable subject matter under Section 101 of the United States
patent statute to encompass micro-organisms but it furthered the debate over
patenting of living material including plants and animals. With the
encouragement and inspiration from the Chakraburty decision, the scientific
community, with extended enthusiasm and spirit, furthered their research in
the field of biotechnology extending its scope to cover other living beings.
The streamlined research in the field resulted in transgenic plants.
Biotechnology proved that it was quite capable of producing transgenic plants
in a hitherto unknown manner by combining the qualities of different plants
and putting them together into an intended plant. The resulting plants were
genetically modified to possess certain special features such as high yield,
resistance to pests, and capacity to withstand drought conditions, which did
not exist earlier. As the progress in biotechnology
witnessed transgenic plants claims for patenting transgenic plants and related
inventions began to increase. Incessant filing of patent applications as such
was the sequel of Chakraburty decision. It was for the first time in 1986 in
Exparte Hibberd a mutant maize plant was claimed for a patent. The patent
examiner rejected the
patent application on the basis that the claim was for a living thing. The patent
examiner viewed the claimed invention as a product of nature and decided that
it was not patentable. However, United States Patent Board of Appeals
overturned the ruling of the examiner to grant patent on maize mutants. The
Board, relying on the principle outlined in Chakraburty that when human
ingenuity was added to a product of nature, it became product of man, decided
the claimed maize mutants as eligible for patent protection. The Board
followed the suit in Chakraburty and extended the philosophy of Chakraburty
to human-made transgenic plants. Soon after this decision the United States
Patent Office started entertaining patent applications claiming plants and
related inventions. A hike in the patent application claiming transgenic plants,
plant cells, and tissues was witnessed. In HiBred International v. JEM AG
Supply Inc., Supp, the United States Court of Appeals for the federal circuit
upheld patents on plants. Therefore, now plants and related inventions such as
plant cells and tissues are patent eligible. Dynamic as any science is
biotechnology is keeping a fast pace breaking new frontiers–pace so fast that
law is running behind it for regulations.
The decision of Diamond v. Ananda Chakraborty had its impact when a plant was claimed for patent for
the first time. The clamants contended the rationality of Diamond v. Anand Chakraborty where it was held
that anything under the sun made by man is patentable. Applying the same rationality claimants
contended that maize mutant plant which the claimed for paent is not available in the nature. They also
contended that the plant they are claiming is the modified form which is different from the natural form and,
hence, by applying the rationality of Diamond v. Ananda Chakraborty patent could be granted. Further it
was contended that there was another law, the United States Plant Variety Rights Law under which
protection can be sought rather than seeking patent. See Jayashree Watal, Intellectual Property Rights in
the WTO and Developing Countries,New Delhi : Oxford University Press, First published in India 2001, Third
impression 2002, pp. 177-82.
3.4 PATENTING OF ANIMALS
3.4.1 ANIMAL BIOTECHNOLOGY
Animal cell science focuse on the biological issues that subtend the
productivity of animal cells in culture .cell couture is no longer considered as
a technique to create cell lines but as an indispensable science to understand
the various cell signalling machanisms, the switches within the cells that
control growth by the control of gene expression .in simple term ,it is the basic
requisite for understanding of the intercellular and intercellular activities of a
cell .cultivation of animal cell is extremely important to the biotechnology
industry. With recent advances in research in manipulating the environment to
enhance cellular growth in vitro , novel compound for therapeutic and
prophylactic use have also been produced. animal cell culture systems have
been genetically engineered to produce clinically important
Patenting of higher life forms : Animals
Micro-organisms such as bacteria, algae, and plants are considered as
lower life forms. Animals are considered as higher life forms in biological
terms. The capacity of animals to think and express makes them different
from lower life forms and hence they are considered as higher life forms along
with human beings. The voyage of biotechnology patent law furthered to
cover animals and related inventions. Once transgenic plants were given
patents, biotechnologists started trying their hands in producing transgenic
animals. The result was new forms of animals with foreign genes called
genetically manipulated animals. Initiating debate over the patenting of
animals for the first time in the history of patent law in 1987, an animal was
claimed for a patent. In Exparte Allen the claim was for oyster, a genetically
modified animal. The patent was opposed on the ground of
product of nature. Opponents contended that animal being a creation of God
was a product of nature and could not be patented. God was the only owner of
products of nature; man could not own it by patenting it. Meanwhile, the
patent office rejected the claim for the invention on the ground of
obviousness, i.e., lack of inventive step. On appeal, the Board of Patent
Appeals and Interferences confirmed the rejection. However, the Board
rejected to affirm that the oysters were naturally occurring subject matter and
consequently left alive the issue of patenting of living organisms. In other
sense the Board accepted that the claimed
oyster is a non-naturally occurring living matter, further animiating the debate
on animal patenting. Meanwhile, patent applications claiming animals, animal
genes, tissues, and other inventions relating to animal genetic material started
pouring in. There was vehement pressure from the biotech industry to grant
patents on animals in the light of its enormous potential and utility of the
claimed inventions. In this background the patent office issued a statement
revealing its stand on animal patenting. It was stated, ‘The patent office now
considers non naturally occurring non-human multi-cellular living organisms,
including animals to be patentable subject matter within the scope of subject
matter under the United States Patent
Statute.’ Based on this policy the United States Patent Office granted the first
patent on an animal. In the year 1988 patent was granted on a genetically
engineered mouse, an Onco–mouse, susceptible to cancer. A foreign gene,
onco gene, was incorporated into the mouse by genetically engineering it,
which made it
susceptible to cancer. The mouse was useful in cancer testing. The patent
office granted patent on the ground that the invention is a non-naturally
occurring and human-made living being. The decision brought animals within
the purview of patentable subject matter. After onco–mouse was patented, the
mouse race continued and at least sixteen patents had been granted on
inventions relating to transgenic mice. The voyage of patent law witnessed
patents on transgenic sheep producing protein in its milk, transgenic pigs that
produced low cholesterol meat, and animals that produced pharmaceuticals in
bioreactors. The race continued and patents were also granted on goat and
cattle expressing diverse protein. The voyage of biotechnology patent law
reached a stage wherein it offered patent protection to genetically modified or
transgenic animals. As per the observations now it is possible to build a farm
of transgenic animals to which patent protection is offered.
However, biotechnology is capable of manipulating higher life forms. Biotechnology industry produced transgenic
animals that possess qualities such as high yield of milk, flesh, faster growth, etc. New forms of animals are produced
through biotechnology by genetically manipulating the existing animals. We have seen animals giving high yield of milk
such a jersey cows. We have seen animals giving high yield of flesh and wool such as hybrid sheep. We also saw animals
which grow fast. How would it be if all these features were found i a single animal? It is possible through biotechnology.
Genes coding for certain features i the animals can be isolated and incorporated into an intended animals which in turn
posses all the features. At the same time genes in the animals can be removed or suppressed to get the desired results.
Genes coding for certain qualities can also be isolated and incorporated into any living being to get the desired results.
Genes in animals coding for certain protei are isolated and commercially produced by incorporating such genes into a
bacteria other micro-organisms.1987 USPO 2d 1425.
See supra 4, p. 173.
3.5 PATENTING OF MICRO ORGANISMS
The 1970s witnessed moves towards patenting living matter, which laid
foundation for the evolution of biotechnology patent law. During this time
there were claims for patents on living matter. In Diamond v. Chakraburty the
claim was for a genetically modified micro-organism capable of eating crude
oil spills. The inventor Chakraburty claimed both the process of producing the
bacteria and the bacteria. For the first time in the history of patent law, a
question arose whether living matter was patenable or not. The patent office
allowed process claims for the method of producing bacteria but the claim for
bacteria was rejected. Chakraburty appealed to the Patent Office Board of
Appeals, where the rejection was affirmed. The Board concluded that
patentable subject matter as enshrined under Section 101
of the United States Patent Code did not encompass living things such as
micro-organisms. The Board did not go into detail whether the invention
involved any inventive step or not. The claim was plainly rejected by stating
that patentable subject matter did not encompass living things. An appeal was
made to the Supreme Court. There was much anxiety and the whole world
was eagerly waiting for the decision. The Supreme Court by a 5:4 majority
overruled the patent examiners, rejection of the patent and held that the United
States patent statute is broad enough to cover living organisms. The Court
viewed that constitution had granted wide powers to the Congress to promote
the progress of science. The Congress has every power to legislate with
respect to the promotion and advancement of science. It was held that the
language of the patent statute was broad enough to encompass protection to
living organisms. While determining, whether the claimed invention came
within the meaning and scope of patentable subject matter, the Court in
particular considered two terms, ‘manufacture’ and ‘composition of matter’,
under Section 101 of the patent law. The Court relied on the decision of
American Fruit Growers while interpreting the term ‘manufacture’ and the
decision of Shell development while interpreting the term ‘composition of
matter’. The Court interpreted the phrase ‘composition of matter’ to
encompass living matter produced through biotechnology. The Court
observed that the claimed bacterium was a composite mixture of the features
of known species, put
together into one species. It was viewed that Chakraburty had genetically
modified the natural bacterium to possess capacity to eat crude oil spills.
Upholding the philosophy of Thomas Jefferson, the author of the first patent
law in the United States that ‘ingenuity should receive liberal encouragement’,
it was held that the invention was a result of human ingenuity and intellectual
labour which should receive liberal encouragement. The Court accepted the
contention of Chakraburty that the bacterium was a non-naturally occurring
human-made micro-organism
which did not exist in nature automatically. Responding to the contentions that
living matter was a product of nature and could not be patented, the Court
held that Chakraburty’s invention was not a product of nature; it was a
product of man, the human role involved in the invention differentiates it from
a product of nature. The Court accepted that the starting point of the invention
was a product of nature, but the inventor had added his ingenuity in making
the bacterium to possess the capacity to eat up oil spills with accuracy and
pace. Naturally, the bacterium did not possess such a feature; there was a role
of human agency in making the bacterium to possess such special skill.
Therefore, the invention was a non-natural
human-made product, a result of human ingenuity and labour. The very fact
that human agency had played a role in making the bacterium to possess
special skill renders the product of nature a product of man. The bacterium
was a product of nature till human intervention whereupon it turned into
product of man. Rejecting the argument that micro-organisms cannot qualify
as patentable subject matter until the Congress expressly authorized such
protection, the Court held that biotechnology was unforeseen by the Congress
when it enacted Section 101 on patentable subject matter. However, the
Congress employed broad general language in drafting Section 101 precisely
because such inventions were often unforeseeable. The Court highlighted the
constitutional objective of promoting the progress of science and also the
philosophy of Jefferson that ingenuity should receive liberal encouragement in
interpreting the patentable subject matter to encompass living matter. At the
time of the judgment there were at least 100 patent
applications pending before the United States Patent and Trademarks Office
(USPTO) that were disposed of on the rationality of the decision. There was
a plethora of patent applications before the USPTO soon after the decision on
Chakraburty. The case had set a new trend, it began a new era of patent law.
The decision had raised the curtain for the evolution of biotechnology patent
law and it opened floodgates for biotechnology patents.
3.6 PATENTING OF HUMAN CELLS AND GENETIC
MATERIAL
The voyage of patent law further continues, as there were moves to
patent human genetic material. The evolution of biotechnology patent law
adds another feather in its cap by extending patenting protection to human
genetic material such as human cells, genes, and DNA. New techniques in
biotechnology such as recombinant DNA technology, gene splicing, and gene
manipulation made the isolation and purification of human cells, genes, gene
sequences, DNA, and DNA sequences possible. These genes, gene sequences,
DNA are called genetic material, which have now become a subject of patent
protection. Genes code for some specific proteins which may have some
medicinal value. These genes, gene sequences, and DNA inside a cell or even
cells and cell lines have been claimed for patent.
For the first time in the history of patent law a human cell line was claimed for
a patent. The cell line was taken from the spleen of a person named John
Moore. This particular cell line was producing valuable antibacterial and
cancer-fighting proteins. The doctors of John Moore identified and isolated
the cell line and applied for patent. The United States Patent Office granted
patent on the cell line, thereby making human cells and genetic material a
subject of patents. As more and more research is being conducted in the field
and enormous utility of genetic material is being identified, a rush began for
claiming patents on specific genetic material like DNA and genes. In Amgen
v. Chugai the claim was for an isolated and purified DNA sequence. It was
for the first time in the history of patent law that a human genetic material,
i.e., DNA was claimed for patent. The claimed DNA codes for a protein called
erythropoietin that boosts red blood cell production. The invention is very
much useful to the people suffering from anemia having red blood cell
deficiency. The inventors wanted to commercialize the invention by patenting
it. Patenting of human genetic material did not attract opposition on the basis
of products of nature unlike patents on plants and animals. Oppositions
concentrated on the actual isolation, possession, and conception of the
inventions. Here the court investigated into the fact whether the inventor has
actually conceived the invention. The court defined the conception to mean
actual knowledge of the invention with its properties and reducing the
invention to successful practice. Considering the invention in the case it was
held that the conception of DNA meant actual knowledge of the DNA
sequence with its physical and chemical properties and experimenting the
DNA successfully. It was found that the inventors actually had the knowledge
of the DNA and had reduced successfully to practice, and eventually patent
was granted. As biotechnological inventions involve conception of different
genetic material or conception of different methods to isolate or employ
genetic material the definition provided for conception is very significant. It
can be said that biotechnology inventions, if actually conceived in the manner
provided in this case, will be eligible for patent. Further, in In re Vaeck the
claim related to manipulating a bacterium to insert a gene. Inventors isolated a
gene and combined it with a stretch of DNA from the bacteria and created
chimeric gene. A patent was claimed in 1991 and the same was
granted.Following the suit in Amgen in In re Bell there were claims on DNA
and RNA coding for human insulin like growth factors, which play a vital role
in the mediation of somatic cell growth on the administration of growth
hormones. As it was decided in the Amgen case that human genetic material is
patentable, oppositions were not against the patenting of human genetic
material but on the specificity and inventive step involved in the invention.
Patent was opposed on the basis of the prior art suggesting for a general
method for isolation of genes and DNA. The prior art was suggestive of a
general method for isolation of genes and DNA. The Federal Circuit held that
a general method for isolating genes or DNA would not render a specific
method of isolating a particular DNA coding for specific human insulin
growth factors obvious, and eventually patent was granted. Here the Federal
Circuit did set forth a principle that a general method suggested for isolating
genes, DNA, or other genetic material would not deprive the inventor, who
invents a specific method, from patent. This decision came as an
encouragement to the biotechnologists as at the time the industry was
regularly involved in isolating infinite number of human genes and DNA. If
one general method for isolating genes and DNA blocks other inventors from
patenting their specific methods, it obstructs the progress of the industry. A
general method always may not succeed or even if it succeeds, there results
may not be accurate. However, specific methods provide for accurate results,
particularly for isolating one specific gene or DNA in the light of infinite
number of genes and DNA present in our body. This approach provided much
needed encouragement to the biotech industry. Biotechnologists became busy
in claiming patents for their specific methods for the isolation of specific
genetic material after the above decision. The
race continued and in In re Deuel the invention related to an isolated and
purified DNA and cDNA (composite DNA) molecules coding for Heparin
Binding Growth Factors (HBGF) were claimed. Heparin Binding Growth
Factors are proteins that stimulate cell division and facilitate the repair or
replacement of damaged or diseased tissue. Patent was opposed on the basis
of the prior art suggesting for a general method for isolation of genes and
DNA. Prior art had also suggested the protein HBGF, with its amino acid
sequences. The Federal Circuit reiterated the principle laid down in In re
Bell’s case and held that prior art suggesting a general method for isolating
DNA molecules would not render a specific method obvious.
Now it is a settled fact that human genetic material is unambiguously
patentable. There is no opposition to the patenting of isolated and purified
human genetic material. The patent law does provide protection to the
inventions of genetic material in an isolated form. The interpretation of the
patentable subject matter under the patent code in an innovative and liberal
way has brought human genetic material within the purview of patentable
subject matter. The law on the patenting of biotechnological inventions now
offers patents to ultramicroscopic human genetic material such as genes,
DNA, and like materials.
927 F.2d 1200, 18 USPQ 2d 1016 (Fed. Cir. 1991).
Brian C. Cannon, ‘Toward a clear standard of obviousness for biotechnology patents’, Cornell
Law Review, Cornell University, March 1994.
991. F.2d 781 (Fed. Cir. 1993).
3.7 PATENTING OF FRAGMENTS OF DNA AND GENES
DNA is made up of sequences. In fact, a gene is the portion of DNA,
which expresses a particular protein. In turn, gene is also a composition of
sequences. Isolation and sequencing of DNA requires isolation and
sequencing of its different sequences. On the same line isolation and
sequencing of gene requires isolation and sequencing of its different
sequences. The 1980s and 1990s witnessed patents on DNA and genes. Late
1990s witnessed claims for small sequences and fragments of DNA and genes.
Essential Sequence Tag (EST) is a part of a sequence from a cDNA molecule.
Essential sequence tags are used in finding the full-length DNA or gene.
Patenting of ESTs proved controversial as it was challenged by a variety of
societies like HUGO (Human Genome Organization). HUGO says that EST
does not involve an inventive step and moreover it lacks substantial and
credible utility. Given the vehement opposition, patenting of EST proved
controversial and eventually the patent office did not prefer to grant patents on
EST. However, arguments in support of patenting EST are that EST can be
used as probes in identifying genetic material. It is useful in identifying full
stretch of genes or DNA. As isolation of any gene or DNA starts with the
isolation of its sequences, EST being a fragment of a gene or DNA comes to
the use for identifying the full stretch of a DNA or gene. In 1997, Clinton
administration announced that the patent office would begin allowing patents
on EST based on their utility as probe. Having received the green signal from
the government, the patent office started entertaining patent applications on
EST. This resulted in a flood of patent applications claiming EST.
Subsequently, on 6 October, 1998 the first patent on EST was issued to Incyte
Pharmaceuticals Inc. By the end of 1998, the same company filed patent
applications for over 1.2 million DNA sequences many of which are of human
origin. Reportedly by the end of 2000, the USPTO had received patent
applications on millions of gene fragments. The sheer numbers of
applications suggest that every human gene at least in part might already be
subject to a patent application.
F. 3d 1552 (Fed. Cir.1995).
3.8 PATENTING OF BIOTECHNOLOGY PROCESSES
AND METHOS
Not only human genetic material but also methods or processes to isolate
such material are claimed for patents. Methods of expressing specific proteins
in vitro (outside the body of animal or human) through incorporation of genes
coding are also claimed for patent. In order to produce a certain protein coded
by a particular gene, the gene is isolated and incorporated into the intended
body say, bacterium. The bacterium as a regular biological process produces
such protein for which it was genetically engineered. On the same lines
methods to produce antibodies45 from the genetic material are also claimed
for patent. In Hybertech Inc. v. Monoclonal Antibodies. Inc.,46the claim was
for an immunoassay (method)47that utilized monoclonal antibodies to
measure the concentration of certain antigens (viruses).48 The goal was to
evolve a process for measuring the quantity of certain antigens in a given
solution. Inventors produced a method to detect antigens by employing
antibodies (proteins) produced inside the body. The invention involves a
method to produce antibodies to fight against antigens in a given solution.
Patent was granted on the invention the first of its kind in developing a
method to employ antibodies against antigens. It was for the first time that the
patent office granted patent on a biotechnological method of employing
antibodies produced by the body’s immune system to fight against antigens.
This patent resulted in a number of patent applications claiming different
methods to raise antibodies and to employ against antigens. In In re Wards the
claim was for an ‘immunoassay’ utilizing monoclonal high affinity IGM
(immunoglobulin) antibodies. The invention involves immunoassay methods
for the detection of hepatitis-B surface antigen by using high-affinity
monoclonal antibodies.50 The invention was a method to produce protein
against specific viruses. The Federal Circuit, relying on the reasoning of
Hybertech decision, held that though it required some experimentation in
practising the invention, the invention is patentable. This case was another
example where a method to utilize antibodies against antigens was claimed.
Perhaps the isolation and purification of genetic material is a herculean task.
In fact, genetic material is not available for easy isolation. The intended
genetic material must be identified before its different parts are isolated. After
isolation the material needs to be purified in order, incorporate it into an
intended body for performing an intended task like producing a specific
protein. As per the latest decisions of the Court of Federal Circuit and the
decisions of the US Patent Office biotechnology processes or methods for
constitute a patentable subject matter
US patent No. 5,817,419, ‘Human Kinase Homologs’ issued to Incyte Pharmaceuticals, Inc. Lislei G. Restaino, Steven
E.Halpern, and Dr Eric L.Tang, ‘Patenting DNA-related inventions in the European Union, United States and Japan: A
trilateral approach or a study in contrast?’ UCLA Journal of Law and Technology, 2003. Antibodies are proteins
produced by the body’s immune system to fight against antigens, i.e., foreign bodies such as disease-causing bacteria and
virus. Antibodies are a class of proteins that help defend the body against invaders such as virus and bacteria. See supra5,
p. 292 802 F. 2d 1367(Fed. Cir. 1986), See also Chisum cases and materials on principles of patentlaw, New York
foundation press, New York, 1998, pp. 287-92 Immunoassay means a method for detecting or measuring antigens by
using antibodiesc as reagents. See supra 5, p. 293.
See supra 40.c858 F.2d 731 (Fed. Cir. 1988). Debra Z. Anderson, ‘How to enable your Biotech Disclosurec for the
United States Patent Application’, Lawyers Journal, Allegheny County Bar Association,c 11 July, 2003.cThe invention
was denied patent by the patent office on the ground of undue experimentationcrequired to practice the invention. In an
appeal made to the Federal Circuit it was viewedcthat the inventor had deposited the invention and the practice of the
invention does requirecsome experimentation. For example, genes are not available to be isolated. A gene is not situated
at a particular place. Gene comprises different fragments. Particular regions of DNA, which expresses proteins, are
called genes. These genes are located in the form of fragments on different regions of a DNA. Isolation of a gene requires
the isolation of its different fragments of DNA.
3.9 ISSUES
3.9.1 PATENTS RELATED INVENTIONS:
CHAPTER 4
4.1 POSISTION IN EUROPEAN UNION
4.2 EVOLUTION OF BIOTECNOLOGY IN EUROPEAN UNION
In Europe, German miners of the Alps seem to have been the first
develop
the notion of monopoly rights in their new processes as far back as in the
thirteenth century. The first more universal patent scheme evolved in Venice,
and then at the height of its international power, in a decree of 1474 which
rewarded inventors of new objects with a limited monopoly on condition that
the invention was disclosed to the state. In England, the Crown started
granting patents in the fifteenth and sixteenth centuries. Queen Elizabeth I
granted the earliest patent to an Italian inventor named Acountius. The Crown
was active in granting monopolistic privileges. However, this practice of
granting monopolies was criticized as it was abused to bestow privileges upon
favourites of the Crown. In this background the Parliament enacted the Statute
of Monopolies in the year 1624, which declared all monopolies and grants by
the Crown as void and contrary to law. The statute of
monopolies being the first English patent statute governed English patent law
for more than 200 years and forms the foundation of the present British patent
system.
In the European patent legislation history there are three significant milestones
contributing to the development of substantive law on patents. The first
milestone was the Paris convention for the protection of industrial property
adopted in 1883. The convention formulates the basic tenants of patent law in
Europe. The convention was formulated as an appreciation to the growth of
intellectual property rights. It intends to protect industrial properties such as
patents, trademarks, designs, etc. Here industrial property should be
understood in its broader sense to encompass agricultural and extractive
industries and to all manufactured or natural products, for example, wines,
grain, tobacco leaf, fruit, cattle, minerals, mineral water, beer, flowers, and
flour. Perhaps biotechnology has its impact on all the
components of industrial property that are offered protection under the Paris
convention. In the agricultural sector, in the production of wines and beer
biotechnology plays a vital role. Hence it can be inferred that though
specifically not mentioned, biotechnology is covered under the convention.
The second milestone in the history of European patent system is the
Strasbourg Convention adopted with an objective of establishing a common
market in Europe. The convention harmonizes the substantive patent law in
terms such as novelty and inventive step. The third milestone in the history of
European patent legislation was the European Patent Convention (EPC) 1973.
The convention provides for common patent-granting system in all European
countries. The convention says that European patents shall be granted for any
inventions which are susceptible to industrial application, which are new, and
which involve an inventive step. The convention prohibits patenting of living
beings produced through essentially biological processes, but it does not
prohibit living beings produced out of non-biological processes. The framers
of the convention seem to have some forethought of patenting living beings
produced out of non-biological processes. In Europe even before the adoption
of the proceedings of the convention, there were claims for patents on living
matter produced through non-biological processes. It seems, due to such
instances the European Union foresaw the growth of biotech industry and
provided for patenting of living beings produced through non- biological
processes. The convention does not state the inventions that are patentable but
also the inventions that are not patentable. Discoveries, scientific theories,
mathematical methods are the few mentioned in the list of inventions not
patentable. Further, the convention states under Article 53(b) that Plants or
animal varieties and essentially biological processes for the production of
plants and animals are not patentable. However this provision does not apply
to microbiological processes or products thereof.” "At the same time the
convention states under Article 53(a) that: ‘Inventions against public order
and morality are not patentable under the convention. The inventions falling
under exception clause do not qualify for patent though they satisfy the
requirements of novelty, industrial application, and inventive step. Inventions
which do not fall under the list of inventions not patentable but do not come
under exceptions to patenability are patentable. When we see the other side of
the coin, it seems that ‘plant and animal
varieties produced through essentially non-biological processes are patenable’
under the convention. The convention expressly says that microbiological
processes and products are patentable. Since essentially biological processes
and products thereof are not patentable it can be inferred that all the other
processes such as microbiological and biotechnological processes and
products82 thereof are patentable. On the same lines it can also be inferred
that products of biotechnological processes or inventions of biotechnology
such as transgenic micro-organisms, transgenic plants, transgenic animals and
isolated and purified human genetic material are patentable. Even the
European Patent Office believes in such an approach as it tried to interpret the
convention liberally to patent inventions produced out of non-biological
processes. These three conventions played a vital role in streamlining the law
on patents in Europe. In particular, EPC seems to have considered the issue of
patenting of biotechnological processes and
products.
Adam Hollyoak and John Torreman, Intellectual Property Law, London : Butterworths, Second Edition, 1998, pp. 37-9.
See supra 5, pp. 13-6 The British patent system has contributed to the development of patent law. The written description
requirement that every invention has to satisfy under the present patent law is a contribution made by the British patent
system. In Liardet v. Johnson [Jarret, English patent system, 26 J.pal.off. Soc’y 762 (1994)] it was held that the
consideration for a patent grant was the specification of the invention. The invention had to be described in a written
form in order to get a patent. This decision set forth the present written description requirement under the British patent
system and later on it was adopted by the patent systems throughout the world. See supra 44International Legal
Instruments of Intellectual Property Rights Law, Department of
Business Laws,Volumes I and II, National Law School of India University, Bangalore, 1998.
Article 1, sub-clause (3) of the Paris Convention on Industrial Property Rights.
4.3 PATENTING OF PLANTS
Patenting of transgenic plants
The progress of biotechnology industry in Europe resulted in research in the
production of transgenic plants. As genetic manipulation in micro- organism
was a success, there ware attempts to manipulate plants genetically. The
biotech industry was successful in genetically manipulating plants and in
inventing new plants. There was encouragement for the research in transgenic
plants through grant of patents. On the basis of the rationality in granting
patents on micro-organisms and biotechnological processes, patents were
being claimed on plants produced through biotechnological processes.
European Patent Office was of the opinion that patents might stimulate further
research in the industry on transgenic plants. The EPO was in favour of
applying the rationality of patenting micro- organisms and biotechnological
processes to similar patent claims on plants also. In Ciba Geigy implying the
stand of the EPO, the European Patent Office
Technical Board of Appeal granted a patent on a plant. The invention was
propagating material for cultivated plant, in particular, seeds of cultivated
plants treated with a chemical agent, i.e., oxime derivative, in order to make it
resistant to agricultural chemicals. A definition of cultivated plants in the
description included all plants, which yielded substances in any form.
Propagating material from such cultivated plants comprised all reproductive
plant components, including plants, which had begun to germinate. The
subject matter of the claim was not an individual variety of plant
distinguishable from any other variety, but the claim related to any cultivated
plants in the form of their propagating material, which had been chemically
treated in a certain way.94 By referring to the exclusions under the European
Patent Convention, the Board observed that Article 53(b) of the EPC
prohibited only the patenting of plants or their propagating material in the
genetically fixed form of the plant variety. It further opined that the
propagating material claimed was not the result of an essentially biologica, but
was a non-natural process of treating cultivated plants in the form of their
propagating material with a chemical oxime derivative according to a set
formula. The Board held that the claimed invention was a non- natural plant,
which was a result of treatment with chemical agents. By interpreting Article
53(b) of EPC restrictively the Board held that non-natural plants did not fall
within the purview of exceptions and are patentable. It was the first case
where non-natural plants produced through a biotechnological process were
claimed and patented in Europe. The decision established a rule that non-
natural plants were patentable under the EPC. Further in 1993, in Plant
Genetic Systems95 genetically modified plant cells and seeds were claimed
for patent. The invention related to the genetic engineering of plants and seeds
in order to make them herbicide resistant. Patent protection was claimed for
plants, plant cells, and seeds possessing a foreign gene capable of resisting a
type of herbicide. The invention intended to develop plants and seeds resistant
to a particular class of herbicides, allowed the plant to grow in the presence of
GSI The invention was opposed from patenting by reason of exception under
Article 53 of the EPC which states : ‘invention the publication or exploitation
of which would be contrary to “ordre public” or morality is excluded from the
purview of patent protection.’ The issues before the court for decision were of
much importance. This case happened to discuss all the provisions in
exception to patentability. Given the raging demand for patenting of living
beings including plants, the decision of the case was very significant. namely,
glutamine synthesis inhibitors (GSI)96. The claimed patent disclosed The
invention was opposed from patenting by reason of exception under Article 53
of the EPC which states : ‘invention the publication or exploitation of which
would be contrary to “ordre public” or morality is excluded from the purview
of patent protection.’ The issues before the court for decision were of much
importance. This case happened to discuss all the provisions in exception to
patentability. Given the raging demand for patenting of living beings
including plants, the decision of the case was very significant. The case had
defined important terms under the EPC and settled many issues that were
troubling the patent office in granting biotech patents. Irrespective of the
outcome, this case had discussed in detail about what constituted ‘ordre
public’ or ‘morality’, ’plant varieties’, ‘essentially biological processes’, and
‘microbiological processes’. Expressing its view on the concept of ‘order
public’ the European Technical Board of Appeal held that ‘ordre public’
covered the protection of public security, physical integrity of individuals, and
also the protection of environment. In that sense any invention the exploitation
of which was likely to breach public peace or social order threatening the
public security or which might seriously prejudice the environment were to be
excluded from patentability as being contrary to ‘ordre public.’the ‘common
heritage of mankind Discussing on the concept of ‘morality’ it was held that
‘morality was related to the belief that some behaviour was right and
acceptable, whereas some other behaviour was wrong. This belief was
founded on the totality of the accepted norms which were deeply rooted in a
particular culture.
Therefore, any invention not in conformity with the conventionally accepted
standards of conduct pertaining to the culture, was to be excluded from
patentability, being contrary to morality. Deciding on the issue whether
patents on seeds and plants went against public order and morality, it was
viewed that seeds and plants per se should not constitute an exception to
patentability under Article 53(b) of the EPC merely because they represented
‘living matter’ on the A survey and opinion poll conducted in Sweden and
Switzerland showed that farmers were neither willing nor against genetic
engineering and production of super crops such as herbicide-resistant plants.
At the same time the survey results showed that farmers were against
patenting of animals and plants. Considering the survey and opinion poll
result the
Board held that survey and opinion poll, being subject to influences and
fluctuations within short time periods in an unforeseen manner, did not
necessarily reflect ‘order public’ or moral norms and could scarcely be
considered decisive per se. Expressing concern over genetically modified
plants and biotechnology patents, the Board opined that plant biotechnology
per se could not be regarded as being more contrary to morality than
traditional selective breeding. It was noted that both traditional breeders, and
molecular biologists, or biotechnologists, objective was to change the property
of a plant by introducing novel genetic material in order to obtain a new and
possibly improved plant. It was also observed that genetic engineering
techniques of biotechnology are more powerful and capable of giving accurate
results and control over genetic modifications. While deciding whether plant
cells and seeds do constitute ‘plant variety’ which was excluded under Article
53(b) of the EPC, the Board held that any claim on or encompassing plant
variety was not patentable. The Board defined a plant variety to mean any
plant grouping within a single botanical taxon of the lowest known rank
characterized by at least one single transmissible characteristic distinguishing
it from other plant groupings and which was However the Board held that
genetically modified plant cells could not be considered as plant varieties. Due
to the current practice of the European Patent Office considering plant cells to
be ‘microbiological products’ it was held that plant cells did not come within
the meaning of plant variety. Further, it was held that plant cells resulting
from microbiological process were considered equal to bacteria and yeast,
which were undoubtedly patentable as per the current practice of the EPO.
Interpreting the concept of ‘essentially biological process’101 it was held that
it depended on the totality of human intervention and its impact on the results
achieved to differentiate a microbiological process from an essentially
biological process. The invention in question for the preparation of hybrid
plants was an essential modification of known biological process and it had
got decisive impact on the desired result of hybrid population. Hence, it is not
an essentially biological process and the exclusion of Article 52(b) of the EPC
did not apply. It was also held that the invention, genetically modified cells, is
a result of microbiological process which differs from an essentially biological
process The board happened to clarify with regard to what constitutes a
‘microbiological process’ and ‘products thereof’ under Article 53(b) of the
EPC. It was held that processes in which micro-organisms or their parts were
used to make or to modify products or in which new micro-organisms are
developed for specific uses were microbiological processes. The ‘products
thereof’, i.e., products of microbiological processes encompass products made
or modified by micro-organisms as well as new micro-organisms as such.
Hence, it was held that the invention of plant cells and seeds in question being
products of microbiological processes were potentially
patentable under EPC This case happened to deal in detail with the exclusion
provisions under EPC. The Board defined important concepts pertinent to
patenting of biotechnological inventions. It was held that plant cells being
products of microbiological processes were patentable. However, it was
decided that the claimed plant, if, encompassed a plant variety, would remain
excluded from patenting. In Ciba Geigy, exclusions were restrictively
interpreted to allow patents on plants, but in Plant Genetic Systems, a more
liberal construction of the exclusions was made in rejecting claims over
plants. This led to the inference that plants produced as a result of genetic
engineering were not patentable since the starting point of every such
invention would be a plant variety
In the meantime the European Union adopted a directive on biotechnology
inventions in the year 1998. The directive nullified the decision of the Plant
Genetic Systems case, in saying that ‘inventions concerning plants shall be
patentable if the technical feasibility of the invention is not confined to a
particular plant variety. Accordingly, now genetically modified plants are
allowed patents even if they encompass a plant variety. The directive requires
its member states to harmonize their law relating to the patenting of
biotechnological invention
Soon after the European Union adopted the directive on biotechnological
invention in Novartis case108 the European Patent Office Enlarged Board of
Appeals happened to decide again on the question of patenting of plants. The
claims were for plants genetically modified to render them resistant to fungi.
The enlarged Board of Appeals ruled that so long as specific plant varieties
were not individually claimed, claim for plants should not be excluded from
patentability. Overturning Plant Genetic Systems decision
Therefore, a patent cannot be denied only on the ground that claim
encompassed a plant variety. Claim that encompassed more than one variety
was thus patentable. The decision, however, nullified the decision in the Plant
Genetic Systems Case in holding a genetically modified plant patentable even
when it encompassed plant varieties and brought the EPC in line with the
European Union directive on the biotechnological inventions. Now, after the
decision in Novartis clarifying that patents could be granted though claims
might encompass plant varieties and the adoption of the directive stating that
genetically modified plants were patentable, plants produced through a
biotechnological process have became undoubtedly patentable Therefore, a
patent cannot be died only on the ground that claim encompassed a plant
variety. Claim that encompassed more than one variety was thus patentable.
The decision, however, nullified the decision in the Plant Genetic Systems
Case in holding a genetically modified plant patentable even when it
encompassed plant varieties and brought the EPC in line withthe European
Union directive on the biotechnological inventions. Now, after the decision in
Novartis clarifying that patents could be granted though claims might
encompass plant varieties and the adoption of the directive stating that
genetically modified plants were patentable, plants produced through a
biotechnological process have became undoubtedly patentable
4.4 PATENTING OF ANIMALS
Patenting of transgenic animals
Biotechnology is capable of manipulating any living being. As the impact
and influence of biotechnology in the plant kingdom was effective and
successful and deep-rooted with transgenic plants coming into being, it
happened with animal kingdom also. Efforts were made in the European
Union to manipulate animals with the aid of biotechnology. Biotechnology
was successful in changing the properties of existing animals or in
manipulating them. The result was transgenic animals and related inventions,
which were being claimed for patents. In the process of evolution of
biotechnology patent law there were claims for patents on different
biotechnological inventions such as micro-organisms and transgenic plants
also on transgenic animals.
The evolution of biotechnology patent law took another turn with patents
being claimed on animals. For the first time in the history of Europe an animal
was claimed for patent In Harward onco mouse.110 The invention involved a
transgenic mammal,111 an animal susceptible to cancer, which was useful in
cancer testing. Inventors produced transgenic mice possessing foreign genes
(oncogenes), which made it susceptible to cancer. The inventor claimed for a
method for producing a transgenic non-human mammal susceptible to cancer
and for a transgenic non-human mammal containing oncogenes. The method
involved introducing an activated oncogene sequence into a non-human
mammal at a stage no later than the eight-cell stagehe evolution of
biotechnology patent law took another turn with patents being claimed on
animals. For the first time in the history of Europe an animal was claimed for
patent In Harward onco mouse.110 The invention involved a transgenic
mammal,111 an animal susceptible to cancer, which was useful in cancer
testing. Inventors produced transgenic mice possessing foreign genes
(oncogenes), which made it susceptible to cancer. The inventor claimed for a
method for producing a transgenic non-human mammal susceptible to cancer
and for a transgenic non-human mammal containing oncogenes. The method
involved introducing an activated oncogene sequence into a non-human
mammal at a stage no later than the eight-cell stage
Initially, patent was refused by the European Patent Office (EPO) examining
division on the ground that the invention was against public order and
morality and also on the ground that the invention encompassed an animal
variety, which is excluded from the purview of patenting. European Patent
Convention under Article 53(a) prohibits patent protection for invention,
exploitation of which is contrary to public order and morality. At the same
time the convention under Article 53(b) prohibits inventions encompassing
animal varieties from patenting.112 The examining division interpreted the
above provision of the Convention to exclude animals from patenting. The
invention was viewed as contrary to public order and morality. Besides, the
claim for non-human mammal was considered as very broad in the light of the
invention describing only a method to produce transgenic mice.
In appeal, the EPO Technical Board of Appeal rejected the interpretation of
Article 53(a) and (b) of the EPC to exclude the present animal invention from
patentability. The Board opined that the examining division was wrong in
refusing the patent application on the ground of exceptions to patentability
under Article 53(a) and (b). As there was no specific mention of animal
invention whether patentable or not, it was inevitable on the part of the Board
to interpret the existing provisions of the Convention to decide the issue. The
Convention provides for exclusions for patenting and also exceptions to
patentability. It was opined that any invention that did not fall under
exclusions or exceptions to patentability is generally patentable. The Board
viewed that as per the language of the convention animal inventions were not
excluded from patenting. Therefore, the issue before
the court was to decide whether the claimed invention did fall under any of the
exclusions under the Convention. In this background the Board happened to
interpret and analyse exceptions to patentability under the Convention such as
‘order public’, ‘morality’, ‘animal variety’, ‘essentially biological process’,
‘microbiological process. While considering exception from patentability
under Article 53(a) of the EPC on the ground of ‘order public’ it was believed
that inventions of biotechnology had too many folds which had to be
considered carefully. These included the suffering of animals, besides,
possible risks to the environment which were to be weighed with the
usefulness of the invention to mankind. The Board remanded the case to the
examining division to examine the above. The examining division viewed that
‘the development of new technologies is normally afflicted with new risks’
and this is an experience mankind has gained in the past. Due to this, the
Board opined that there should be careful preponderance of the risk vis–a–vis
the positive aspects of such inventions. The Board viewed that if the risk
associated with the invention was more and could not be balanced with the
positive aspects of such invention it was likely to lead to the question of
‘public order’ and ‘morality’ and patent could be rejected. Where higher life
forms were involved in the new technology, it was not only the risk, which,
must be considered, but also the possible harm, likely to happen to such
higher life forms
In the instant case different interests were involved which required balancing;
One, there was the basic interest of mankind to remedy widespread and
dangerous diseases; two, the environment should be protected against the
uncontrolled dissemination of unwanted genes; and, three cruelty to animals
should be avoided. If the invention caused any kind of imbalance of
environment or suffering to animal, it would be justified to deny patents on
the ground of public order and morality.113 The Board opined that the
usefulness to mankind of the present invention could not be denied. Cancer
was one of the most frequent causes of death in many countries of the world
and also caused severe suffering. Any contribution to the development of a
new anti-cancer treatment was, therefore, a benefit to mankind and must be
regarded as valuable and highly welcomed by everybody. The present
invention gave rise to a smaller number of animals needed in corresponding
conventional testing. Such being the case, the present invention contributed to
a reduction of the overall extent of animal suffering. As there were no
alternatives to animal testing in the given context, animal test models were
indispensable for cancer research. Therefore, in the interest of mankind the
invention could be allowed though it gave rise to animal suffering
Considering the possible risks to the environment, on the release of
genetically modified inventions the Board had taken the purpose of the
invention into account. It was viewed that the purpose of the invention was to
provide animal test models, which were to be used exclusively in the
laboratory under controlled condition by qualified staff. Such being the case,
risk of uncontrolled release would not arise except on the possible misuse or
blatant ignorance on the part of the laboratory personnel carrying out the tests.
This should not be a ground to deny grant of patent. Concluding its discussion
the examining division held that the claimed invention was not immoral or
contrary to public order due to the fact that the invention was very useful in
cancer testing. Usefulness to mankind outweighed animal suffering . While
considering whether the invention constitutes ‘animal variety’ within the
meaning of EPC (a), which probibits animal variety from being patented, it
was viewed that the claimed invention was a transgenic animal and did not
constitute an animal variety. Considering the fact that European patents were
not granted for essentially biological process the Board found that the claimed
process involved insertion of an oncogene into a vector – in the present case
plasmid – which required to be microinjected into the egg at an early
embryonic stage, and this was not possible through essentially biological
processes. The Board viewed the claimed invention as a result . of
microbiological process, which is not excluded form patenting. The Board
considered ‘microbiological processes’ as an exception to the essentially
biological processes and held the same as patentable. It was opined that cells
and genes are microbiological material and any process which involve
microbiological material is a microbiological process
The Board considered the argument that the claim for producing non-human
mammalian was too broad as the invention described only a method to
produce transgenic mice. It was held that ‘a biological invention is considered
sufficient, it clearly indicated at least one way in which skilled person could
accomplish it. The method need not disclose all the ways of practising the
invention on different mammals. Hence, it was held that the disclosure of a
non-natural method to produce transgenic mice is enough to practise the
method on other non-human mammals and the claim for the method of
producing transgenic non-human mammals was valid; hence, eventually
patent was granted on onco-mouse. It was for the first time in the history of
European patent law that a patent was granted on a transgenic mouse. This
case led to interpretation and discussion in detail of the various provisions of
the EPC with vis-a-vis the patentability of biotechnology
inventions. This decision cleared all doubts as to the interpretation of EPC
exclusion provisions for patenting of biotechnology inventions. With this
decision now the EPC encompassed patents to transgenic animals produced
through biotechnology.
Exceptions to patentability under Article 53 of the EPC See supra 28, p. 153. See also supra 88, pp. 32-3. T 19/90 (1990)
OJEPO 476, Tech. Bd App; (1991) E.P.O, R.525, Ex. D. A mammalian is that animal that breastfeeds its offspring.
Human being is also a mammal as human beings breastfeed their offspring. See supra 92, pp. 62-7.See supra 88, p.
31.Article 53(b) of the EPC says essentially biological processes are not patentable. Bar of patenting of essentially
biological processes does not cover microbiological processes. The present invention is a result of microbiological
process wherein an oncogene is inserted
into the mice at an early stage of eight cells.
4.5 PATENTING OF MICRO ORGANISMS
In fact, Europe was ahead of the United States in patenting living beings.
In 1969 in Germany, a patent was claimed on a method for breeding doves
with red plumage.83 German patent office rejected the patent on the ground
that the method was not repeatable and the Supreme Court of Germany
confirmed the same. It was the first case where a process for producing living
matter was claimed in the European Union. Seemingly, it was the first case to
open the door to the patenting of biotechnology inventions.84 Further, in the
early 1970s, five years before the United States Supreme Court decision in
Chakraburty case, the German Federal Supreme Court upheld patent
protection for new micro-organisms if the inventor were to demonstrate a
reproducible way for its generation.85 In the meantime the
European Union adopted the European Patent Convention laying down a
comprehensive framework on the law relating to patents. The above decision
of the German Supreme Court was proved controversial in view of the EPC
excluding the patenting of plant and animal varieties, or essentially biological
processes for their production. The German Supreme Court’s decision can
be viewed from the positive side of the EPC. The Convention excludes patents
for products of essentially biological processes but it does not exclude
patenting of products of non-biological processes. Therefore, it can be inferred
indirectly or impliedly that the EPC laid the foundation for patenting of living
beings. For the first time after the adoption of the European Patent
Convention, which seemingly laid the foundation for the patenting of living
beings in Genentech-I/Polypeptide expression86 a living being was claimed
for patent. The invention was a plasmid, a micro-organism suitable for
transforming a bacterial host, which included an expression control sequence,
or ‘regulon’ which could enable the expression of foreign DNA as a
recoverable polypeptide. The applicants invented a general principle for
enabling plasmids to control the expression of polypeptides (proteins) in
bacteria. The European Patent Appeals Board opined that only essentially
biological processes and concomitant products are excluded under the
convention,
but non-biological processes and products thereof are not excluded. Therefore
non-biological processes and the sequel products are patentable under the
convention. The Board viewed the present invention as a product of
biotechnological processes which in the opinion of the Board do not constitute
essentially biological processes. It was held that the present invention, not
being a product of essentially biological process, is patentable. The decision
of the Board represents the patent office approach in patenting products of
processes other than essentially biological processes. The decision assured the
inventors that patents are granted for products of biotechnological processes
and established the rule that micro-organisms
are patentable in the European Union.
Microbiological process is defined under the convention to mean ‘any process involving or performed upon or resulting
in microbiological material.’ See Chapter VI, Rule 23B(6) of EPC. See also, Article 2(1)(b). Biotechnology invention is
defined under the European Patent Convention to mean, ‘any invention which concern a product consisting of or
containing biological material or process by means of which biological material is produced, processed or used.’ See
Chapter VI, Rule 23B(2) of EPC.. Adelman et al. (1998), p. 156. See supra 28.Wagner (1976), p. 335.
4.6 PATENTING OF HUMAN CELL AND GENETIC MATERIAL
After transgenic animals it was the turn of human genetic material which
was claimed for patents in the European Union. As biotechnology achived
success in manipulating animals, its next target was to manipulate human
genetic material. Biotechnology is capable of isolating and purifying human
genetic material and exploiting commercially. Human genetic material such as
cells, genes, gene sequences, DNA, and DNA sequences and fragments are
being claimed for patents. Along with human genetic material, products of
such genetic material such as proteins, antibodies, etc., are also claimed for
patents. For the first time in Europe in Relaxin case the EPO happened to
decide whether human genetic material are patentable or not. The claim was
for a gene coding for a hormone called relaxin. The hormone was expressed in
the body of a pregnant woman during the time of delivery to relax the body
that laboured and suffered pain in delivering the baby. It was the first case
where a patent for genetic material was claimed. The patent was opposed on
the plea that human genetic material did not
constitute a patentable subject matter under the EPC. Further, it was argued
that patenting of human genes amounting to owning property rights
achievement in Hepatitis-B as many people were working for the same result.
The decision of the EPO Board favoured the biotech industry. However, the
House of Lords decision went against the desires of the industry. Both the
decisions came at the same time. But the decision of the EPO Board had
binding force throughout the European Union. The decision of the Board
brought human genetic material like; gene, DNA within the purview of the
patent law.
Hence, the situation now in Europe is that living matter produced through
biotechnology such as micro-organisms, plants and related inventions, animals
and related inventions, human genetic materials such as cells, genes, and DNA
and parts thereof are indisputably patentable. Though there are no specific
legislations on patenting of biotechnology, the existing patent laws have been
interpreted in such a way as to encompass patent protection to
biotechnological inventions resulting in the emergence of biotechnology
patent law within the existing patent law. The voyage of the emerging
biotechnology patent law started with patenting of micro- organisms. Later,
the plants were given patent protection, followed by patents on animals, and
finally granting patent protection to human genetic material. Probably, there
ends the voyage of biotechnology patent law as there is a
universal conviction in prohibiting human being from the purview of
patentability. As the international society is against patenting of human being,
the quest should end with patenting of human genetic material. Though the
law has evolved on biotechnology, the international society is worried about
the regulation of the biotech industry. As it is proved that biotechnology is
capable of manipulating any living being, it may move towards producing
transgenic human beings, which is against the ethical and moral standards of
the society. Such inventions may give rise to problems of public order.
Though the international society is committed to prohibit research on
transgenic human being in the consideration of developments
in the industry, it is felt that there is a need to regulate the field by evolving
proper and adequate norms, safeguarding the ethical and moral standards of
society
Meanwhile, in the background of enormous progress of the biotech industry
and strong demands for proper legal protection of biotechnological inventions,
and on account of the fact that there is inadequate protection to the
biotechnological inventions in the existing patent system, the European Union
adopted a directive on the legal protection of biotechnological inventions.
The directive is a major breakthrough in the evolution of biotechnology patent
law as it provides a blueprint on the legal protection of biotechnological
inventions. The directive acknowledges and respects various decisions by the
European Patent Office and its Technical Board in granting patents on non-
natural living beings produced through biotechnology. The directive gives
statutory recognition to the various judicial decisions hitherto made on the
protection of biotechnological inventions
Microbiological processes are patentable under the convention in contrast to essentially biological processes.
(1995) Official Journal of the European Patent Office 388; (1995) E.P.O R 541.
See Modern Law Review, 1998, p. 675.
Article 52.
4.7 ISSUES
CHAPTER 5
5.1 POSISITION IN INDIA
India as a member of the World Trade Organization (WTO) needs to conform to certain
agreements, which form the basis of the WTO. One such agreement is TRIPs which was a
culmination of discussions on the need for uniform laws regarding patents in the member
countries of the WTO. The TRIPs came into force on January 1, 1995,with immediate
effect but with certain exceptions for which provisions (specifically) for the members from
developing world) were made which were thought to come into force by the year 2000.
However, these provisions could be delayed for an additional period of 5 years subject to
certain conditions, implying that the deadlines was January 1, 2005 for achieving
compliance with the TRIPs Agreement.
To fulfill the TRIPs objectives, India amended the Patent Act, 1970, three times in a span
of 5 years. The first was in the year 1999, to give effect to the above said provisions and
thereby meeting the first deadline. Some of these provisions were made retrospective from
1995. The second was made in 2002 keeping in mind the same objective, which brought
the Indian law substantial compliance with the agreement. The latest amendment with an
objective of making the Indian Patents Act, TRIPs compliant came into force from January
1, 2005. In this connections, the deletion of Section 5 of the Indian Patents Act, 1970, and
amendments to certain definitions in section 2 made the Indian Act TRIPs complaint. The
important guidelines laid down by the TRIPs which are significant for patents in
biotechnology will be discussed in the following section.
TEXTBOOK OF BIOTECHNOLOGY
EDITOR H.K.DAS 4TH EDITION WILEY INDIA PVT.LTD PAGE NO 1287 22.3 TRIPS AND PATENT LAW
(WTO)WORLD TRADE ORGANIZATION AND TRIPS
TRIPs : Article 27
Article 27, Article 28, Article 29 and Article 30 are relevant for the IPRs
related to patents. Of these, Article 27 is an important article for amending the
patent law in the member countries and for the same reason is being quoted
below. The patent law that will be discussed in this chapter refers to the
amended Indian Patents Act, 1970, as in force January 1,2005.
The basic requirements of novelty, inventive step and capable of industrial
application have been laid down as the minimum criteria for determining the
patentability of an invention. Article 27.1 does not clearly define these
concepts, but leaves it to the member countries to decide and formulate the
law that will be applicable to their territory, keeping in mind the above
essentials.
Criteria for Patenting Inventions
Novelty is the first requirement. It indicates that the invention claiming a
patent must be new, which implies that it should be different from prior art
Prior art refers to any material published or act performed or anything known
in the world before the date of filing to the patent application. Certain
countries also require that the subject matter of the application has not been
publicly used or known or publicly demonstrated or disclosed in oral or
written form before the date of applying for the patent. All these clauses
basically signify that the subject matter of the patent application should not be
a part of the public domain when the invention is being claimed through the
filing of the patent application.
Inventive step requires that the invention is not obvious (also known as the
test of nonobviousness) to a person skilled in the art at the date and time the
invention was actually made by that person. Various courts have described the
presence of an inventive step in different ways, but have all emphasized the
necessity of the same.
Industrial application requires that invention should have practical use and
utility. In the US, any invention with utility attached to it without perceptible
industrial application finds its place as a patentable subject matter.
The second part of Article 27.1 refers to the nondiscrimination between the
various member countries, and most importantly the equality assigned to
inventions from all fields of technology. This is important since it implies that
biotechnological inventions cannot be denied patents because of their nature.
Article 27.2 states that members may exclude from patentability such
inventions as is ‘necessary to protect ordre public or morality, including to
protect human, animal or may be made merely because the exploitation is
prohibited by their law. This concept has been incorporated in Section 3 (b) of
the Patent Act. The term ‘ordre public’ has been stated as public order in the
Indian Patents Act, and it is substantially related to must contain an ‘enabling
disclosure’. This implies that the details of the invention must be disclosed in
such a manner so as to enable a person skilled in the art to use or essential,
since it serves the purpose underlying the grant of a patent, which is beneficial
statutory monopoly granted to the inventor. The time period accorded for
protection of the invention has been set uniformly, at 20 years, for all
categories of inventions. Article 33 of the TRIPs states that the ‘term of
protection shall not end before the expiration of a period of twenty years
counted from the date of filing’.
Article 27.3 of the TRIPs has been the cause of great controversy and
deliberations. The implications of this part of the Article are enormous.
Therapeutic and surgical methods are not patentable because they depend on
the skill of the doctor aor surgeon practicing the method, and therefore cannot
be patented as a process. The US is the only country where such methods are
patentable subject matter, but clauses for protection of medical practitioners
against the suits for infringement have also been provided.
Article 27 (3) a(b) clearly obliges member states to grant patent protection for
the following inventions:
1. Microorganisms;
2. nonessential biological process for the production of plants and
animals;
3. protection of plants is granted under the Sui Generis system of
protection that each state (member country) evolves for itself, or patent
protection or a combination of both.
However, Indian law provides protection in the form of the Plant
Variety Protection and Farmers Rights Act. The Indian Patent Act,
1970 will now be dealt with in detail.
Patent Law in India
The recent amendments to the Patents Act, 1970 have incorporated
many important changes that haave a singnificant bearaing on the patent law
in Indiaa.
Section 2 (1) (j) defines an invention’ as ‘ a new product or process
involving an inventive step and capable of industrial apaplication’. The term
‘inventivie step’ is defined in Section 2 (1) (ja), which states that ‘inventive
step means aa feature of an invention that involves technical advance as
comparaed to the existing knowledge or having economic significance or both
and that makes the invention no obvious to a person skilled in the art’
Patents Act, 1970.
Thus, the patentability requirements as per the Indian Patents Act are as
follows:
1. It should be new (novelty).
2. It should involve an inventive step (nonobviousness of the invention).
3. It should be capable of industrial application.
These sections lay down the minimum requirements of an
invention to be patentable. However, the invention should not be
covered by the list of exclusion provided in the Act. Section 3 provides
a list of whata are not inventions (exclusions) under the Indian Patents
Act which is discussed in detail in the next subsection.
Section 3: What are not inventions?
The following are not inventions within the meaning of this Act:
(a) An invention which is frivolous or which claims anything obvisouly
contrary to well establhished natural laws;
(b) An invenion the primary or intended use or commericla explitation
of which could be contrary to public order or morality or which
causes serious prejudcie to human, animal or plant life or health or
to the environment;
(c) The mere discovery of a scientific principle or the formulation of an
abstract theory or discovery of any living thing or non-living
substances occurring in nature;
(d) The mere discovery of any new property or new use for a known
substance which does not result in the enhancement of the known
efficacy of that substance or the mere discovery of any new property
or new use for a known substance or of the mere use of a known
process results in a new product or employs at least one new
reactant;
Explanation: For the purposes of this clause, salts, esters, ethers,
polymorphs, metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives of known substance
shall be considered to be the same substance, unless they differ significantly
in properties with regard to efficacy.
(e) a substance obtained by a mere admixture resulting only in the
aggregation of the properties of the components thereof or a process
for producing such substance;
(f) the mere arrangement or re-arrangement or duplication of known
devices each functioning independently of one another in a known
way;
(g) (omitted);
(h) a method of agriculture or horticulture;
(i) any process for the medicinal, surgical, curative, prophylactic,
diagnostic, therapeutic or other treatment of human beings or any
process for a similar treatment of animals to render them free of
disease or to increase their economic value or that of their products;
(j) plants and animals in whole and any part thereof other than micro-
organisms but including seeds, varieties and species and essentially
biological processes for production or propagation of plants and
animals.
(k) A mathematical or business method or a computer program per se;
(l) A literary, dramatic, musical or artistic work or any other aesthetic
creation whatsoever including cinematographic works and television
productions;
(m) A mere scheme or rule or method of performing mental act or
method of playing;
(n) A presentation of information;
(o) Topography of integrated circuits;
(p) An invention which in effect, is traditional knowledge or which is an
aggregation or duplication of known properties of traditionally
known component or components.
Another exception given in Section 4 of the Patents Act is that
inventions relating to atomic energy are not patentable subject matter in India.
The requirements of the TRIPs agreement have been further complied
with by the Indian Patents Act, by the provision in Section 53 of the Indian
Patents Act, which cite the term of the patent, and states that the ‘term of
every patent… shall be twenty years from the date of filing of the apaplication
for the patent’. Therefore, during these 20 year, the patent holder can
commercially exploit the invention in the market, since he/she holds a
monopoly, or can authorize any other person to do so, or license such usage.
TEXTBOOK OF BIOTECHNOLOGY
EDITOR H.K.DAS 4TH EDITION WILEY INDIA PVT.LTD PAGE NO 1287 22.3 TRIPS AND PATENT LAW
(WTO)WORLD TRADE ORGANIZATION AND TRIPS
Patents in Biotechnology
It is important to discuss and understand the patenting of biotechnological
inventions in various jurisdictions including the Indian scenario. In the field of
biotechnology, the TRPs Agreement clearly excludes the patenting of plant
and animals. Following this, India has implemented the same, as given in Sub-
section (j) of Section 2 of the Indian Patents Act. Most countries have merely
complied with the given TRIPs provisions, but India has gone one step further
and excluded ‘parts of plants or animals’ from being subject matter of patent.
However, for the grant of patent the said invention should not fall under the
exclusions as given in the Indian Act (Section 3).
The biotechnology industry is devoed to the development of
commercially valuable therapeutic, biochemical and pharmaceutical products.
Many of these products and processes involve manipulation of DNA moeculs
and their encoded proteins. Methods of cloning genes and moving them
beteen organisms have become common place.
In the field of biotechnology a number of patents have been granted world
wide in the area of:
1. R-DNA technology;
2. Microorganisms’
3. Vaccines;
4. Polymerase chain reaction (PCR);
5. DNA/RNA and protein sequences;
6. DNA sequencing methods;
7. Hybridoma technology;
8. Stem cell technology;
9. Plant tissue culture;
In India, a number of the above inventions are patentable. However,
some of these are excluded from patentability (see Section 3 of the Patents
Act, 1970) as discussed above. Patents are granted to all processes and some
products involving R-DNA (R-DNAA) technology. The patents involving the
R-DNa technology are discussed in detail in the following subsection.
Patents in R-DNA Technology
R-DNA technology has been routinely and extensively used for the purpose of
manipulating the function of the genes to our advantage. R-DNA technology
begins with the isolation of a gene of interest. The gene is then inserted into a
vector and cloned. The commonly used vectors are bacterial plasmids and
viral phages. The gene of interest (foreign DNA) is integrated into the plasmid
or phage, and this is referred to as R-DNA. Before introducing the vector4
containing the foreign DNA into host cells to express the protein, it is cloned.
Cloning in necessary to produce numerous copies of the DNA because the
initial supply is inadequate to insert into host cells. Once the vector is isolated,
it is introduced into the desired host cells such as mammalian, yeast or
bacterial cells. The host cells then synthesize the foreign protein from the R-
DNA from which the foreign or recombinant protein can be isolated and
purified in large amounts.
R-DNA technology is not only an important tool in scientific research,
but it has impacted the diagnosis and treatment of diseases and genetic
disorders in many areas of medicine. Some of the many important functions of
F-DNA technology are: isolation of large quantities of pure protein,
identification of mutations, diagnosis of affected and carrier states for
hereditary disease, transfer of genes from one organism to another, and
mapping of human genes on chromosomes.
R-DNA is very useful for combating one of the greatest problems in
plant food production, the destruction of crops by plant viruses or insect pests.
For example, by transferring the coat-protein gene of the zucchini yellow
mosaic virus to squash plants that had previously sustained great damage
from the virus, it has been possible to create transgenic squash plants having
tolerance to this virus. Scientists have also developed transgenic potato and
strawberry plants that are frost –resistant; potatoes, corn, tobacco and cotton
that resist attacks by certain insect pests; and soybeans, cotton, corn and
oilseed rape (the source of canola oil) that have increased resistance to certain
weed-killing chemicals cailed herbicides. R-DNA has also been used to
improve crop yield. Gene that controls plant height, known as a dwarfing
gene, has been transferred from a what plant to other cereal plants, such as
barley, rye and oats. The transferred gene causes the new plant to produce
more grain and a shorter stalk with fewer leaves. The shorter plant also resists
damage from wind and rain better than taller varieties. R-DNA also has been
used to clone large quantities of the gene responsible for the cattle growth
hormone bovine somatotropin (BST) in the bacterium Escherichia coli. The
hormone is then extracted from the bacterium, purified and injected into dairy
cows, incr3easaing their milk production by 10% to 15%.
Gene splicing technique is one of the important techniques of R- DNA
technology. The use of gene splicing technique for animal food production has
become a common place strategy. Gene splicing involves cutting out part of
the DNA in a gene and adding new DNA in its place. The process is entirely
chemical with restriction enzymes used as chemical ‘scissors’. Depending on
the type of restriction enzyme used, different parts of the DNA can be
targeted. A specific enzyme will split apart a specific strand of DNA leaving
behind a gap in the genetic code where new DNA can then be added. The new
strand of DNA added binds to the ends of the DNA strands that were
originally cut. Another enzyme called ligase is used in this repair process. The
modified stretch of DNA fragment formed is called the R-DNA and it is
capable of expressing desired protein. Gene splicing process is carried out in
most cases to repair a defective gene, where the imparted function of the gene
is functionally modified, producing engineered include salmon, which has
been modified for faster growth, and trout, which has been altered so that
they are more resistant to infection by a blood virus.
Patentable Processes Involving R-DNAA Technology
1. Method of transforming cells or complete biological entity such as
microbes, plants or animals.
2. Method of cloning and expression of desired genes in the same or
different cell.
3. Method of optimizing gene expressions to produce useful thereapeutic
proteins.
4. Method of producing a transgenic plant or animal.
5. Method of screening and detection of specific DNA sequences.
6. Method of designing probes, primers, recombinant vectors.
7. Method of modifying genomic sequences.
Examples of some of the granted patents sufficient to comprehend the types
listed above are ‘Method of producing a vaccine for prevention or treatment of
gastric infection’, ‘Process for preparing a non-glycosylated human chorionic
gonadotropin hormone (BHCG) useful as birth control vaccine’, ‘A method of
producing killed Vibrio cholera vaccine’, ‘Process for preparation of a vaccine
against tuberculosis’ and ‘In vitro method of producing Hepatitis E viral (hev)
antigen used as a vaccine or for detection of anti-hev antibodies’.
Patentable Products Involving R-DNAa Technology
1. Different cloning vehicles (vectors) such as plasmids, cosmids,
phagemids, etc.
2. Probes, primers and oligonuleotides.
3. Vaccines and other useful proteins.
4. Transgenic/genetically modified organisms.
In a nutshell, subject matter considered to be aa product/part of this
technology comprises a major portion of all the biotechnology-related
invention. This technology protection in the biotech domain. The following
are some of the various biotechnology patents granted using the techniques of
R-DNA technology
However, patentability of processes and products emplying tools of R-
DNA technology to obtain higher living organisms has been a debatable issue
since a along time. The famous Harvard Oncomouse case (refer to Section
22.10) has been one such landmark case that was successful to agreat extent in
laying down the guidelines addressing this issue.
Article 37 (3) (b) of the TRIPs Agreement states that plants and animlas
other than miroorgaanisms and the processes for producing them shall not be
patentable, but the Member Stataes shalal provide a Sui Generis system or an
alternate form of protection or patent protection or a combination of both to
safeguard the new varieties evolved as a
Patent related to R-DNA technology
Result of genetic modification. India has enacted the ‘Protection of Plant
Varieties and Farmers Rights Act, 2002’ as the Sui Generis system for the
above mentioned purpose. However in the US, there exist three methods of
protection for plant- related inventions, namely the Utility Patent, Plant Patent
(PPA) and the Protection of Plant Varieties (under PVPA). Moreover, in the
US double protection for an invention is possible. Since the utility patents and
plant patents are more stringent forms of protection as compared to PVPA, the
US provides double protection. If it is a plant variety it can be protected under
the utility patent and PVPA.
The issue of patentability of animals is more controversial and will be
discussed in detail, with specific reference to the Harvard Oncomouse case,
which caused a lot of debate worldwide.
For a fair understanding of all the issues discussed so far, patenting of
the different aspects like genes, micro organisms, plants and animals will be
explained in detail in the next sections.
Patenting of DNA/RNA Sequences
A gene is a structural unit of inheritance in living organisms. It is a segment of
DNA that has a particular purpose, thata is it codes for a protein or a specific
enzyme. The strands of DNA on which the genes occur are organized into
chromosomes. Each gene or an organism provides a blueprint for the synthesis
(viaa RNA) of enzymes and other proteins at a specific time. Genes govern
both the structure and metabolic functions of the cells, and thus of the entire
organism. Genes located in reproductive cells pass their information to the
next generation.
Gene patenting is a abroad term that refers to the patenting of a process
that involves isolation of DNA or associated materials like RNA as well as
chemical substances related to DNA such as proteins and peptides. For
patenting of DNA/RNA sequences, ESTs, SNPs, the following steps should
be undertaken:
1. Identify novel genetic sequences;
2. Specify the resulting product from the sequence;
3. Specify how the product functions in nature (use);
4. Enable one skilled in the filed to use the sequence for its stated purpose.
More than 10,000 patent apaplications have been filed on genes or gene
sequences worldwide. Granting of gene patents encourages genetic
research. Patents help biotech companies to recoup the investments that
they employ in indentifying genes and their associated use, novel
medical applications like gene therapy and diagnostics. Moreover, to
have gene patents makes business sense, since it provides the patentee a
clear cut business advantage over his competitors. With a different
view, majority of researchers in the biotech area argue that gene /DNA
patents discourage investment in genetic research. The pharmaceutical
industry would certainly do better if firms were able to work freely with
any gene instead of focusing much on the patenting aspect.
The patenting of genes and /or DNA sequences is popular in the
US and the EU. In India, no product patent protection of DNA/RNA or
genes per se was allowed till January 2005. However, a process using
R-DNA technology to produce a protein involving a gene or DNA
sequence was a patentable subject matter. Under the process patent,
genes and protein sequences may be described in patent application.
Once genetic material, which may include a gene, a DNA sequence,
cDNA, expressed sequence tag (EST) or single nucleotide
polymorphism (SNP), has been isolated from its natural state and is
able to meet the criteria of patentability, only then a patent is granted.
For several years patent offices have granted product or process patents
for genetic material (especially in countries like the US and the EU).
5.2 EVOLUTION OF BIOTECHNOLOGY IN INDIA
EVOLUTION OF BIOTECHNOLOGY PATENT LAW IN INDIA
In the latter part of the nineteenth century, new inventions in the field
of art, process, method or manner of manufacture, machinery, apparatus, and
other substances produced by manufacturers were on increase in India and the
inventors became very much interested in getting their inventions protected.
Inventors were much concerned about the enforcement of their inventions that
others should not copy or infringe their inventions. In this background British
rulers enacted the first ever patent law in India, i.e., Indian Patents and
Designs Act, 1911, to offer patent protection to the inventions. Later, in the
light of changing economic and political scenarios the Act was thought as not
comprehensive and outdated. After independence, since 1953, there were
moves to consolidate the patent law by bringing up a new comprehensive
legislation. At last in 1970, government enacted the Patents Act of 1970. At
the time of this enactment biotechnology had already
started affecting the world, particularly in the United States and in the
European Union. In these countries claiming of biotechnology inventions for
patents started in the 1960s
The Patents Act, 1970, highlights that an invention that satisfies the
universally accepted requirements of patentability such as novelty, inventive
step, and industrial application is patentable. The Act defines invention to
mean any new and useful art, process, method or manner of manufacture,
machine, apparatus or other articles produced by a manufacturer and
includes any new and useful improvement of any of them. The Act does not
specify the inventions which are patentable, but it illustrates subject matters
that are not patentable. The Act in its original form allows patenting of
processes but it does not consider patenting of products. Further, Indian
Patents Act enacted in the year 1970 does not mention anything about
biotechnological invention. The reason was that at that time biotechnology
was not developed in India. After biotech industry started flourishing in the
United States and in the European Union some momentum developed in India.
Once patents were granted for different biotechnology inventions in the USA
and in the European Union the demand for adopting same approach gained
significance throughout the world including India. As a matter of fact, the
judiciary was responsible for the evolution of patent law on biotechnological
invention in the US as well as in the European
Union. Following some judicial intervention patent laws were suitably
amended and efforts were made to grant patents on biotechnological
inventions. This momentum set new trends in the history of patent law and
influenced the adoption of international conventions like Trade Related
Intellectual Property Rights (TRIPS). The agreement states that patents shall
be made available to all types of inventions in all fields of science and
technology. The agreement mandates patenting of biotechnology inventions in
the member states. After ratifying TRIPS, India modified all its intellectual
property laws including patents law and started marching towards patenting of
biotechnological inventions.
To fulfil its obligation under the TRIPS agreement to provide patent
protection to all kinds of invention in all the fields of science and technology
including biotechnological inventions, India has thrice amended its patent law.
The first amendment was made in the year 1999; this amendment was brought
into effect retrospectively from 1995. The basic objective of this amendment
was to provide for mailbox applications for agricultural and pharmaceutical
inventions. The amendment brought changes in the original.
Act to extend patent protection to inventions relating to manufacture of
chemical substances intended for use or capable of being used as food or as
drug. These changes are significant in the light of the prosperity of the
biotechnology industry which were by now capable of isolating genetic
material coding for certain chemical substances in any living being which are
useful in the preparation of drugs and medicine. In fact, the 1999 amendment
provides only for accepting patent applications claming for inventions relating
to agriculture and pharmaceuticals. After the amendment thousands of
applications were filed before the Indian patent offices claiming inventions
relating to pharmaceuticals and agricultural products, among which
considerable number of applications were relating to biotechnological
inventions like chemical substances isolated from the body of living beings.
However, all these applications were kept in mailbox which was opened on 1
January, 2005 and are now under processing
For the second time India amended its patent law in the year 2002 bringing
major changes in allowing patenting of products of chemical, biochemical,
biotechnological process as well as micro-organism. Chemical processes are
patentable under the original Act. However, 2002 amendment added
explanation to chemical process, which states: ‘Chemical processes include
biochemical, biotechnological and microbiological processes.’ As chemical
processes are patentable with the added explanation to it, now ‘biochemical,
biotechnological, and microbiological processes are also patentable.
Biotechnological inventions concer n biochemical, biotechnological, and
microbiological processes in producing non-natural, human-made, and
transgenic living beings such as micro-organisms, plants, animals, isolating
human genetic material, and also in producing the end products of such
genetic materials. Such being the case, the amendment is
significant in encouraging and promoting biotechnological inventions in India
as it seems to cover almost all the above-mentioned biotechnological
inventions. Till the time of this amendment the term ‘invention’ under the
patent law was encompassing only processes but the amendment included the
term ‘product’ within the meaning of invention. After the amendment, the
definition to invention stands as ‘a new “product” or process involving an
inventive step and capable of industrial application. After this amendment,
products as well as processes in all the fields of science and technology are
patentable in India. The amendment brought a few major changes in the Act,
which is worth discussing here. The amendment restructures Section 3 of the
original Act, which illustrates subjects which are not considered inventions or
which are not patentable. The amendment adds the following provisions to
Section 3 of the Act, which is significant in technology are patentable in India.
The amendment brought a few major changes in the Act, which is worth
discussing here. The amendment restructures Section 3 of the original Act,
which illustrates subjects which are not considered inventions or which are
not patentable. The amendment adds the following provisions to Section 3 of
the Act, which is significant in consideration of patenting of biotechnological
inventions
An invention the primary or intended use of commercial exploitation of which
could be contrary to public order or morality or which causes serious
prejudice to human, animal or plant life or health or to the environment.
Discovery of any living thing or non-living substances occurring in nature
Therapeutic and diagnostic or other treatment of human beings or animals
Plants and animals in whole or any part thereof other than ‘micro- organisms’,
but including seeds, varieties and species and essentially biological processes
for production or propagation of plants and animals
The above-mentioned subjects are not considered inventions and are not
patentable. These amended provisions incorporate TRIPS provisions under
Article 27 in the patent law. The amendment states that micro- organisms are
patentable but plant and animal varieties and essentially biological processes
for the production of the same are excluded from the purview of patent
protection. However, it is mentioned that the above exclusion does not apply
to microbiological processes and products thereof. In the sense
microbiological processes and products thereof are patentable. At the same
time it is further stated that discovery of any living thing is not patentable.
Discovery of a living thing existing in nature does not involve any human
interference and hence is not patentable. On the same lines natural things
produced out of natural or essentially biological processes, which do not
involve any human interference, are not patentable. It implies that a non-
natural process that involves some technical interference to a natural process
is patentable. Technical interference to a natural or essentially biological
process renders it non-biological, which is patentable. On the same lines
products of biotechnological process produced through some technical
interference to natural process are non-natural, hence patentable.
In March 2005, for the third time India amended its patent law. The
amendment recognizes Budapest treaty for the deposit of micro-organisms for
the purpose of patent procedure. Patent applications claiming biotechnological
inventions involving living matter shall be accompanied by a deposit of the
invention in any depository recognized under the treaty.
As it may not be possible to describe a biotechnology invention, the treaty
recognizes the practice of depositing the invention to compensate for the
written description. In order to fulfil TRIPS mandates of providing patent
protection to biotechnological inventions, India recognized the Budapest
treaty, which facilitates the deposit of biotechnology inventions. Further, the
2005 amendment totally omits Section 5 of the original Act which restricted
patents only to the methods or processes of manufacture. The 1999
amendment altered this section by inserting sub-clause (2), which provided
exception to the main provision for product patenting of drugs and medicines.
With the latest amendment totally omitting this section, now both products as
well as processes are patentable. In the field of biotechnology, processes as
well as products are claimed for patents. Biotechnology inventions such as
micro-organisms, and genetically modified plants and animals are products of
biotechnological processes. So these are
being claimed for patent. Further, methods or processes to manipulate living
beings genetically or to produce genetically engineered living beings are also
claimed for patent.
The emergence of biotechnology patent law in India can be traced back to
the TRIPS agreement and the amendments made to the patent law by virtue of
TRIPS agreement. But even earlier to implementing the TRIPS agreement a
patent on a living being was granted. Dominico, a subsidiary of American
Home Remedies, was granted a patent on a process for the preparation of
infectious bursitis vaccine. The vaccine is useful in protecting poultry against
infectious bursitis. Initially, the patent office rejected the patent claim and an
appeal was made to the Calcutta High Court. The High Court held that there is
no bar for patenting a claim on a living being or living process. The Court
interpreted the term ‘manufacture’ under the patent law to include any living
being or living process and directed the patent office to grant patent. It was the
first instance where a living process was patented in India
With the amendments made to the patent law fulfilling obligations under the
TRIPS agreement there emerged biotechnology patent law in India. Unlike in
the United States and European Union where biotechnology patent law is a
result of judicial pronouncements, in India the emergence of biotechnology
patent law is a result of ratifying international conventions and obligations
under such conventions. Having ratified the TRIPS agreement, which
mandates for patent protection to biotechnological inventions, in India micro-
organisms are now patentable. However, the stand of India is not very clear
with regard to the patenting of non-naturally produced plant, and animals. We
shall have to wait and see whether India follows the path of the US and
Europe in holding non-natural living beings produced through
microbiological, biochemical, and biotechnological
processes as patentable or not
Further, research in human genetics (one among different spheres in
biotechnology) is not lagging behind too far in India. On account of enormous
potential of human genetics research there is a definite growth in the sphere of
human genetics, in India. In the absence of legal provisions on the regulation
of human genetics, the Indian Council of Medical Research (ICMR) brought
guidelines to regulate research in human genetics. The guidelines basically
focus on the ethical issues involved in human genetics and intend to safeguard
ethics and human rights in the human genetic research. The guidelines provide
for a comprehensive mechanism for the regulation of human genetics with the
establishment of ethics committees to evaluate research in human genetics. In
the absence of legal framework on the issues and the guidelines hold good.
Meanwhile, the Government of India is thinking of introducing legislation on
the basis of the guidelines issued by the ICMR. Further, the Government of
India brought DNA safety guidelines in the year 1994 to regulate the use,
storage, and release of genetic material in research. The DNA safety
guidelines are considered as a pre-arrangement for ensuring safety in usage of
biotechnological products and processes, which are offered protection by
virtue of amendments made to the patent Act. The consequences of such
patenting such as use of biotechnological inventions like DNA and gene
should be regulated and safety should be ensured. The DNA safety guidelines
intend to ensure safety in using, and storing of DNA and genes for research in
biotechnology. It can be inferred that as far as biotechnology and its
regulation is concerned, India is not lagging behind too far as it has got
considerable legal mechanism to patent, regulate, and monitor
biotechnological inventions.
Many foreign biotech companies have filed patent applications in India on
different biotechnological inventions. Till date, there is no substantive case
law or patent office reports or records in India on the patenting of
biotechnological inventions. It is expected that in future there may be judicial
pronouncements and patent office reports on the patenting of biotechnological
inventions as India is turning out to be a biotech hub in the near future. As
biotechnological inventions are based on biological sources, as the starting
point of any biotechnological invention is biological material, having
enormous biological resources in India is going to generate definite growth in
the biotech industry. Recognizing the significance of the upcoming sector of
biotechnology in the present world, the government of India has come out
with certain strategic plans to boost the industry. Further, the Government of
India has announced special assistance and scholarships for studies and
research in biotechnology to boost expertise and manpower in the sector.
Besides bringing changes in the patent law to give protection to
biotechnological inventions, having made all the legal arrangement, India is
ready to face the challenges that may arise as a result of biotechnological
inventions and researches in different spheres
On the whole the evolution of biotechnology patent law can be traced back to
the Constitution of America, which intends to foster the progress of science
and technology. The US judiciary has played an important role in the
emergence of biotechnology patent law through its interpretation of the patent
law. The liberal approach of the US judiciary was supported by the US Patent
Office by granting patents on biotechnological inventions. The suits in US
judiciary and the patent office were followed by other nations. Initially the
European Union was ahead of the US as there were patent claims on
biotechnological inventions involving life. However it was the US judiciary
which gave green signal to the emergence of biotechnology patent law
through its judgment in Chakraburty. The decision in Chakraburty is a
milestone and is the starting point in the evolution of biotechnology patent
law. The decision had its far-reaching impact where it influenced the entire
world. Even today, courts while adjudicating matters involving biotechnology
inventions, and patent offices, while granting patents on biotechnology
inventions, follow the rationality of Chakraburty.
The approach of the US is very liberal. Their philosophy is that anything
under the sun made by man is patentable. The evolution of biotechnology
patent law is heavily influenced by this philosophy evolved by Thomas
Jefferson, the author of American patent law. The European Union was quick
enough to follow the philosophy of America in liberally interpreting the
existing patent laws to provide patent protection to biotechnological
inventions. Later, the entire world including India followed the US cases by
amending their local laws or bringing suitable legislations to give patent
protection to biotechnological inventions. Meanwhile, the TRIPS agreement
also postulates patenting of inventions in all the fields of science and
including living beings produced through biotechnology. It is felt that the
coming into being of the TRIPS agreement has streamlined and uniformed
the law relating to biotechnological inventions. Though having faced strong
oppositions and objections the evolution of biotechnology patent law is
complete and all inventions of biotechnology like micro-organisms, plants,
animals, and human genetic material including different methods to produce
the same are now considered patentable
Patents Act as amended in March 2005 India allowed filing of mailbox patent applications on agricultural and
pharmaceutical
inventions from 1999. Many of those applications contain claims for biotechnological
inventions in relation to agricultural and pharmaceutical industry. On 1-1-2005 mailboxes
were opened for the processing of applications. Since 2002, by amending patent law, patents
are made available to living beings produced through biotechnology and on patent
applications living beings started pouring in. Finally with the 2005 amendment, all the
requirements for giving patent protection were fulfilled.
5.3 PATENTABLITY SUBJECT MATTER IN INDIA
Patentability of Biotechnology Inventions
Inventions are patented on the basis of certain criteria. It is universally
recognized that an invention must satisfy a few requirements such as novelty,
non-obviousness, and industrial applications and written description before a
patent is granted. It is important to note that the three universally recognized
criteria of patentability, namely, novelty, non-obviousness, and industrial
applicability or utility applies to all inventions including biotechnological
inventions. However, patenting of life or living beings produced through
biotechnology commands special attention due to inherent complexities of the
nature of biotechnology inventions. Difficulty is felt in patenting a living
being mainly due to the following three reasons
It is doubtful whether patent protection will be granted to living matters.
Biotechnology inventions are difficult to describe.
How to consider biotechnological new finds : as inventions or as discoveries.
It is felt that the requirements of the traditional patent law are not
enough to test the patentability of biotechnological inventions. In case of
biotechnological inventions it is quiet difficult to differentiate between an
invention and a discovery. Since biotechnological inventions involve living
beings, it requires special attention before a patent is granted. Due to the
inherent complexities and technicalities, sometimes biotechnological
inventions cannot be described in the written specification. To overcome this
problem a solution was evolved in the form of deposit of the invention in any
recognized depositories. The Budapest treaty recognizes international
depositories where inventions related to living matter can be deposited and
maintained for the purpose of patent protection. The deposit of the invention
enables the patent examiner to test the genuineness of the invention before
Jayashree Watal, Intellectual Property Rights in the WTO and Developing Countries, New
Delhi : Oxford University Press, First published 2001, Third impression 2002, p. 132.
M.S. Swaminathan. An Introduction to the Guiding Principles in the Decisions on Patent
Law, Delhi: Bahri Brothers, 2000, p. 331.
Budapest treaty, 1977, provides for the establishment and recognition of international
depositories to deposit inventions of life forms and other biotechnological inventions for
the grant of patent along with the patent application.
Budapest treaty was signed and done at Budapest, in 1977. Any member of the Paris
Convention may become party as per Article 15 of the treaty. See, Manish Arora, Guide to
Patent Law, Delhi : Universal Publishing Co., 2000, p. 410.
the grant of a patent. It is recommended that in case of claiming
biotechnological inventions for patents, the deposit of the invention shall
accompany the patent application. Therefore, a biotechnological invention
must satisfy the requirement of deposit of the invention along with the usual
patentability requirements. Hence, it is inferred that patentability of
biotechnological inventions depends on satisfying the regular requirements
under the patent laws along with the deposit of the invention. The essential
requirements that a biotechnological invention or an invention involving
living beings must meet the following criteria to be eligible for patents:
Patentable subject matter.
Novelty
Non-obviousness (inventive step).
Industrially applicable (utility).
Written description of disclosure of the invention and the deposit of the
invention
PATENTABLE SUBJECT MATTER
The first and foremost requirement is that an invention should fall within the
ambit of patentable subject matter. Inventions falling within the purview of
patentable subject matter are only eligible for patent protection. The
components of patentable subject matter were not initially uniform in different
countries. However, with the coming into being of TRIPS, there is uniformity
in bringing inventions within the scope of patentable subject matter in broad
terms. It states that patents shall be made available for any invention, whether
products or process, in all fields of technology provided that they are new,
involve an inventive step, and are capable of industrial application. It further
states that patents shall be available without discrimination as to the place of
invention, the field of technology, and whether the products are imported or
locally produced. However, members states of the TRIPS agreement may
exclude from patentability inventions, including inventions of life forms of
biotechnology, on grounds of public order, morality, protection of human,
animal or plant life, or health, or to avoid serious prejudice to the
environment. Members states may also exclude from patentability and also
diagnostic, therapeutic and surgical methods for the treatment of humans or
animals; plants and animals and essentially biological processes for the
production of plants or animals. However, it is believed that micro-
Article 27 of the TRIPS agreement.
Kevin W. Meccobe, ‘The January 1999 review of Article 27 of the TRIPS agreement, for
diverging views of developed and developing countries toward the patentability of
biotechnology’, Journal of Intellectual Property Law, Fall, 1998. See also 6J. Intelle. Prop.
L.41.
The TRIPS agreement Article 27, sub-clauses (2) and (3).
organisms, plants, and animals produced through non-biological or
microbiological processes could be patented under the agreement. Therefore,
it is inferred that biotechnological inventions resulting out of biotechnological
processes, which do not come within the meaning of essentially biological
processes, are patentable.
Invention v. Discovery
It is universally accepted that patents are given for inventions and not for
discoveries. It has long been established that discoveries are not patentable.
Invention is something newly designed or created or the activity of designing
or creating new things. Discovery is the act of finding something that had not
been known before. The term invention is not defined under TRIPs or under
other international conventions on patents like the Paris convention or the
Patent cooperation treaty. Even the recent European directive on
biotechnological invention does not define the term invention. The US patent
statute defines the term invention to mean any invention or discovery. As per
the US patent law, there is no difference between an invention and discovery.
However, discovery amounts to the finding of a thing that is existing in the
nature but not known before, whereas invention means creation of design of
something totally new that was not there before.
The philosophy of patent law states that inventions can be living things.
At the same time discoveries can also be living things. It is believed that
discovery of living beings existing in nature is not patentable but inventions of
new living beings that do not exist in nature are patentable. It is felt that a
discovery does not involve creation or design of new thing, hence, it is not
patentable. Almost all patent laws throughout the world say that discoveries of
substances found in nature do not constitute an invention and are excludable
from the grant of patent. Strictly speaking, inventions of biotechnology are not
totally new but are manipulated living beings found in nature. Therefore, there
is a need to draw a distinguishing line between a discovery and an invention in
the light of patenting products of
All unicellular organisms with dimensions beneath the limits of vision, which can be propagated and manipulated in a laboratory, are termed as micro-organisms. Micro- organism includes bacteria and yeasts as also fungi, algae, protozoa, plasmids, viruses. P.K. Vasudeva, Patenting Biotech Products: Complex Issues EPW Commentary, 14-20 October, 2000. Cambridge Dictionary of American English, Cambridge : Cambridge University Press, 2000.
Paris convention for the protection of industrial property, 1983, as amended in 1979. Patent cooperation treaty, 1970, modified in 1984 European directive on the legal protection of biotechnological inventions, 1998. United States Patent Act, Section 100 Dr K.V. Swaminathan. An introduction to the Guiding Principles in the Decisions on Patent Law, Delhi : Bahri Brothers, p. 224.
A mere discovery of something that exists in nature, forming part of the state of the art
(prior art) is not patentable. Dr T. Ramakrishna, Biotechnology and Intellectual Property Rights, Bangalore : Centre for Intellectual Property Rights Research and Advocacy (CIPRA), National Law School of India University, 2003.
biotechnology. The very first objection against patenting of living beings is
that living beings are discoveries or products of nature existing and found
in nature. In fact, biotechnological inventions are based on products found
in nature.
The starting point or raw material for these inventions is biological
material found in nature. It is believed that finding of biological things
existing in nature amounts to discovery. It is also believed that the
manipulation of pre-existing biological resources in nature gives rise to
biotechnological inventions. Perhaps human intervention makes a product of
biotechnology different from a natural biological product. Human intervention
to the biological resources yields new, non-natural, man-made, and hitherto
not existing living beings. Here the distinction between a pre- existing
biological product and a human-intervened, human-made, biotechnological
product is very thin. The distinction relevant to patentability, between the
‘discovery’ of something that exists in nature and the invention and creation
of something new, involving a predetermined degree of human effort, or
invention is, in practice, difficult to make in the field of biotechnology. One
of the contentious issues raised on aspect of biotechnological inventions is
that of the extent to which the traditional concept of invention can be applied
to protect these inventions.
Biotechnology is notable for designing or creating new things that were
not existing hithesto. Biotechnological inventions are the sequal of human
ingenuity and intellect to the existing natural resources. Finding of biological
things in nature amounts to discovery. However, adding human ingenuity to
such biological things gives rise to an invention. Therefore, till the addition of
human ingenuity a biological product remains a discovery and the application
of the human ingenuity thereafter makes it an invention. However, the
complication arises due to the fact that it is becoming increasingly difficult to
determine where ‘discovery’ ends and ‘invention’ begins. This issue is
resolved more through judicial decisions and patent office practices on the
facts and circumstances of each case rather than through clear-cut criteria laid
down in law.
The case law pronouncements have made it clear that finding of a product of
nature is a discovery. A product of nature becomes a product of man due to
the intervention of human being or due to the application of human ingenuity.
It is to say that, a product of nature through some human intervention becomes
product of man. This human intervention to the product of nature gives it a
new existence, making it possess some special features which it did not have
earlier, thus making it an invention. On the whole it creates a new living entity
with some special characteristic features, which were not in existence earlier.
Therefore, product of nature through some human intervention becomes a
product of man, which does amount to an invention. On the same lines the
process of isolating living entities from its natural surroundings in purified
form is patentable. Further, the
result of such a process, the natural living entities in the isolated and purified
form, are also patentable.
See supra 1, pp. 132–3. See supra 15, p. 329.
1. Patentable subject matter in India
In India only inventions are patentable but not discoveries. There is a clear
distinction between inventions and discoveries as the law specifies that only
inventions constitute patentable subject matter. Indian patent law defines
invention under Section 2(j) to mean: a new product or process involving an
inventive step and capable of industrial application. Here inventive step means
a feature that makes the invention not obvious to a person skilled in the art.
Indian patent law does not provide for subjects that are not patentable, instead
it does provide what is not patentable. Indian patent law provides for an
illustrative list where is has mentioned the subjects that are not patentable.
Any subject matter, which does not fall within the purview of the
illustrated list, does constitute a patentable subject matter. The list has
been updated and modified to comply with the provisions of the TRIPS
agreement. The Indian Patents Act states that the
The European Union Directive on the legal protection of biotechnology inventions,
1988,
Article 5. See Jasmine Chambers, ‘Patent eligibility of biotechnological inventions in
the
United States, Europe and Japan’. How much patent policy is public policy, George
Washington International Law Review, 2002.
European Union directive on the legal protection of biotechnology invention, 1998.
Leslie G. Restaino, Steven E. Halpern, and Dr Eric L. Tang, ‘patenting DNA related
inventions in the European Union, United States and Japan: A trilateral approach or
a
study in contrast?’ UCLS Journal of Law & Technology, J.L & Tech.2, 2003. The
Patents of India (as amended in 2005), Section 3.
The Indian Patents Act, as amended in 2002. India having signed the TRIPS
agreement
has made necessary amendments to its patent law to fulfil its obligations under the
agreement. The coming into being of the TRIPS agreement has made
biotechnological
inventions universally patentable.
following are not inventions and do not constitute patentable subject
Matter.
1. Inventions against natural laws.
2. Inventions contrary to public order and morality.
3. Discovery of a living thing occurring in nature.
4. A claim for a duplication of an earlier work.
5. Methods of treatment for human beings or animals.
6. Plants and animals in whole or in part, and essentially biological
processes for the production of plants and animals.
However, micro-organisms and such other inventions of biotechnology,
both products as well as processes, do constitute patentable subject matter.
India has amended its patent law in 2002 to bring life and living beings
created through biotechnology within the purview of patentable subject
matter. The original patent act states that chemical processes do form part of
patentable subject matter. The term chemical process is redefined through
amendments to include biochemical, biotechnological, and microbiological
process. As per the modified definition of the chemical process it is implied
that biotechnological processes and products of such processes are
unambiguously patentable. However, there are no decided case laws in India
on the patentability of biotechnological inventions. Meanwhile, patent laws
universally exclude certain inventions from the purview of patentable subject
matter. An invention, which falls within the purview of exclusions, cannot be
patented though it satisfies the requirements of novelty, inventive step, and
usefulness. The following inventions including certain biotechnological
inventions do not constitute patentable subject matter:
(1) Discoveries.
(2) Inventions against public order and morality, such as:
(a) Human body, discovery of its elements and genes in natural form
(isolation of human genes and gene sequences are patentable if isolated
by technical means), processes for cloning human beings;
(b) Processes for modifying the germ line genetic identity of human beings;
uses of human embryos for industrial or commercial purposes; and
For illustrative list of subject matters not patentable under the Act see, Sec. 3 of the
Indian Patents Act as amended in 2002. See Manish Arora, supra 4.
Inserted by amendment in 2002, to comply with the provisions of the TRIPS. Section 3
of the Indian Patents Act, as amended in 2002.
Indian Patents (Amendment) Act, 2002.
Section 5 of the Indian Patents Act as amended in 2005. With the amendment in 2002
chemical processes are given meaning to include
biochemical, biotechnological, and microbiological processes. See explanation given for
chemical process under Section 5 of the Act.
processes for modifying the genetic identity of animals which are likely to
cause them suffering without any substantial medical benefit to man or
animal, and also animals resulting from such processes.
(3) Plants, animals, and essentially biological processes. (Microbiological
and non-biological processes and products resulting from such
processes seem to be patentable.)
After the Chakraburty decision in the United States, throughout the
world living beings were recognized as patentable subject matter. As the
biotechnology industry progressed and engendered modern-day miracles of
enormous human values, there was a strong demand to include biotechnology
— invented living matter within the realm of patentable subject matter. Due to
the enormous impact of the field of biotechnology on the society and on the
day-to-day life of human being, it was considered necessary to include
biotechnology inventions within the gamut of patentable subject matter. This
proposal has got a strong back push from the decisions of the law courts of the
United States and Europe as well as from the practices of the United States
and the European Union patent offices.
Given the fact that research in biotechnology is growing day-by-day
promising many things to mankind, now patentable subject matter is believed
to include novel, non-obvious microbes, plants, animals, natural and synthetic
compounds, genes, proteins, DNA, RNA, recombinant cells, proteins
expressed by genes in recombinant cell lines, and methods of expressing
protein in animals and mammals. Methods of preparing proteins, processes for
recovery of proteins, processes for medically delivering recombinant proteins
and methods of altering natural properties of plants such as stress, disease, or
pest resistance are also recognized as patentable subject matter. The TRIPS
agreement has changed the contours of patent law by recognizing
biotechnological inventions as patentable subject matter. Now universally,
biotechnology inventions do constitute patentable subject matter. There are a
few universally accepted requirements such as novelty, inventive step,
industrial application, and written description on satisfaction of which
biotechnological inventions are patentable.
Howard B. Rockman, Intellectual Property Law for Engineers and Scientists, New
Jersy :
Wiley Interscience 2004.
TRIPS agreement aims to make available patents irrespective of the field of
inventions or
place of work. See Article; 27 sub-clause (1). See, European patent Convention Art.
5See
S. 35.U.S.C, Section 101. See, UK Patent Act, 1977, and also the Indian Patents Act
as
amended in 2002. Ramappa, Intellectual Property Rights under WTO, Tasks
beforeIndiaNew Delhi and
Allahabad. Wheeler Publishing, 2000, p. 133. TRIPS came into force from 1 January,
1995
for developed countries for developing and least developed countries there was
given a
transition period of ten years, which ended on 1 January, 2005. Now TRIPS
agreement in force for all the member states throughout the world.
See supra 1.
2.NOVELTY OF BIOTECHNOLOGICAL INVENTIONS
If an invention falls within the scope of patentable subject matter, the next
step is to test its novelty. As per the first modern patent statute enacted in
Venice in 1474, every person who shall build any new and ingenious device,
not previously made, shall be granted an exclusive right to use and operate the
device. The TRIPS agreement says that patents shall be available for any
inventions, whether products or processes, in all fields of technology provided
they are new. Any person who contributes some thing new to the society,
who brings out something novel, hitherto not known to the society, is eligible
for patent grant.
Novelty of biotechnology inventions in India
Novelty is not defined in the patent law of India. But invention is defined to
mean a new product or process involving an inventive step and capable of
industrial application. The Indian Patents Act defines inventive step and
industrial application but it does not define the term novelty. Hence it is left
to the patent office and the courts to define and mean the term novelty. As per
the definition given to the term invention a subject matter must be new to
constitute an invention. The Patents Act specifically states that a few subject
matters are not inventions. In doing so, it indirectly states that such subject
matters are not novel or new. In particular, subject matters such as discoveries
and finding of a living thing or substances occurring in
Article 53 of the EPC.
See decisions in oncomouse, plant genetic systems, Novartis, and Biogen.
The availability of a full-length gene does not preclude the novelty of a DNA fragment
coding for such gene. See supra 70.
Section 2(1)(j) of the Patents Act of India as amended in 2005.
nature are considered as not new and do not constitute an invention. Further,
plants, animals, and essentially biological processes are not considered new
and do not constitute an invention.
However, micro-organisms are considered new and can be patented.
Further, human genetic material in isolated and purified form is also
considered new invention. For the first time in the history of Indian patent law
a living process was claimed for patent. The process was useful in preparation
of a vaccine against infectious disease in poultry. The applicants contended
that the process was new and was patentable. The patent office initially
rejected the patent on the ground that it was a living process, which as not
new, and the same did not constitute invention. In appeal the Calcutta High
Court held that there is no bar in the patent law to patent a new living process
or living product. The High Court accepted the contention of the applicant that
the claimed living process is new and directed the patent office to grant patent
on the invention.
In the light of the TRIPS agreement considering biotechnological
inventions as new, India being a signatory to the agreement, amended its
patent law to implement the agreement. Now with the amendments to the
patent law biotechnological inventions, both products and processes, are
considered new. There was no strong debate in India unlike in the US on the
novelty of biotechnological inventions. As the matter is settled in developed
countries like the US and in the European Union that biotechnological
inventions are novel over and above the pre-existing biological products there
was no difficulty for India to follow suit.
3. Inventive step of biotechnology inventions in India(Non –
obviousness)
In India patents are granted for inventions involving an inventive step.
Inventive step is defined to mean a feature that makes the invention not
obvious to a person skilled in the art. Any new product or process that
involves an inventive step is patentable in India. In India the patent law
provides that when an application for patent is made, the patent examiner will
have to conduct an investigation to find the relevant prior art. If in the
investigation it is found that the invention has been anticipated by publication
in India or elsewhere before the date of the applicant’s filing of the complete
specification, the patent shall not be granted. In such circumstances the
invention falls within the realm of prior art, the knowledge in the public
domain involving no inventive step. Such knowledge in the public domain
being obvious to a person skilled in the relevant art shall not be given patent.
The requirement is no different with reference to biotechnology inventions.
However, there is no substantive case law development with regard to
inventive step in the biotechnology inventions in India.
For the first time in India inventive step involved in a biotechnology
invention had come before the courts in Dimminaco A.G. v. Controller of
Patents Designs & others The Calcutta High Court was confronted with a
question whether the claimed invention relating to a process for preparation of
infectious bursitis vaccine did involve inventive step and whether the claimed
subject matter constituted invention under the Indian Patents Act. The vaccine
was useful for protecting poultry against contagious bursitis infection. The
inventors contended that the process claimed involved certain chemical steps
under specific scientific conditions. The patent office initially rejected the
patent application by stating that living virus or living process did not
constitute invention under the Indian Patents Act. However, the Calcutta High
Court held that there was no statutory bar to patent living processes or product
that involved inventive step. In the instant case the process claimed did
involve certain inventive step, as it required certain chemical steps to be taken
in the production of the vaccine. The High Court directed the patent office to
grant patent on the claimed process. Therefore, as per the decision of the
Calcutta High Court a biotechnology invention involving a new process or
product could be patented if it involved an inventive step. Further, as per the
patent law if the invention was anticipated
The Indian Patents Act as amended in 2005, Section 2(j) : Invention.
Ibid. Section 2(ja) Inventive step. Indian Patents Act as amended in 2005.
Under the Indian Patents Act, the examiner is a person who will scrutinize the patent application
and conduct patent search to find relevant prior art.
191. The Indian Patents Act (as amended in 2005). Section 13, sub-clauses (1) to (4), See
also Manish Arora, Guide to Patent Law, Universal Law Publishing Co. Pvt. Ltd, Delhi,
2002, pp. 27-8.
192. See supra 17, p. 38.
in the prior art or is published, used, or patented, it did not involve an
inventive step. In case of biotechnology inventions also the claimed invention
did not constitute an inventive step if it was anticipated or published or used
or patented earlier or in any way formed part of the prior art.
However, nowhere in the United States patent law or in the Indian
patent law the term prior art is used or defined. The European Patent
Convention uses the term ‘state of the art’ which is equivalent to prior art and
states that state of the art comprises everything that is made available to the
public by means of a written or oral description or by use in any other way
before the date of filing of the European patent application. The United States
patent law, the European Patent Convention, and the patent law in India state
that any invention which is known or published or patented, being part of the
prior art, is obvious and does not involve inventive step. Therefore, an
invention, which is a part of the prior art, does not involve inventive step and
is not patentable. The invention shall be a leap forward from the state of the
art or it shall be a step forward from the already existing knowledge that is
prior art. It shall be an advancement of existing knowledge in the public
domain. It implies that courts while determining the obviousness of any
invention shall have to consider the scope of the prior art. In fact, law courts
have taken into consideration the knowledge in the public domain or the state
of the art in deciding the obviousness of an invention. The presumption is that
on the basis of prior art, if an invention becomes obvious to the person having
skill in the relevant art, such invention does not constitute an inventive step
and must not be patented.
4. UTILITY OR INDUSTRIAL APPLICATION
An invention must be useful and capable of industrial application in order to
be patented. There must be some demonstrable utility or specific benefit from
an invention. The invention must have some practical utility in the form of
immediate benefit to the public. As regards the conditions of industrial
applicability, no special considerations should apply to biotechnology
inventions. The requirement of industrial applicability shall be satisfied not at
the time of filing of patent application but at the time of grant of the patent. It
implies that at the time of filing the patent application if the invention has no
practical utility or industrial application, nevertheless patent shall be granted,
if the inventor could establish the utility before the date of the grant of patent.
US Patent Code, Section 101. See also, Patents Act of England, 1977, See supra 65, p. 729. See supra 15, p. 330.
Novelty and non-obviousness shall be established at the time of filing of application but industrial application shall be established at the time of granting of patent. See supra 15, p. 330.
Utility of biotechnology inventions
Utility poses a greater concern for chemical and biological inventions. The
utility of the invention shall be described in a written form along with the
written specification of the invention. The utility of biotechnology inventions
is almost undisputed except a few overtones. To illustrate, genetically
engineered plants give benefits such as high yield resistance to pests, weeds,
and herbicides. Likewise, a genetically engineered animal gives benefits such
as high yield of milk, wool or flesh. However, the utility of biotechnological
inventions such as DNA or gene remains unknown until the gene’s function is
characterized and the activity of its product is determined. Hence it is a
difficult task to identify the utility of a gene or DNA.
Requirement of Industrial application of biotechnology
inventions in India
The patent law of India states that any new product or process involving
inventive step and capable of industrial application does constitute an
invention and is patentable. The expression ‘capable of industrial application
in relation to an invention’ means that the invention is capable of being made
or used in an industry. The requirement of industrial application of inventions
in India is no different from the industrial requirement of Europe or utility
requirement of the US. However, there
In June 2000 a technical meeting of Trilateral Patent Offices took place. There was consensuson
the patenting practice of biotechnological inventions. As a result of thimeeting some
conclusions were made and added final report of the project. The Indian Patents Act as amended in 2005, Section 2(j). Ibid., Section 2(ac).
is no substantial case law development with regard to the industrial
application of biotechnology inventions in India as the industry is in an infant
stage. In Dimminaco AG v. Controller of Patents Designs & others for the
first time, utility of a biotechnology invention was demonstrated. The
invention related to a process for preparation of infectious bursitis vaccine.
The vaccine was useful for protecting poultry against contagious bursitis
infection. Initially the patent office rejected the patent application on the
ground that the claim did not constitute an invention. But the utility of the
invention was not disputed.
On appeal the Calcutta High Court decided that the claims constitute
invention as it involves certain chemical steps to be taken under certain
scientific conditions. At no stage the utility of the invention was questioned
implying the fact that almost all the biotechnology inventions are having
certain utility of industrial application. Likewise, the utility of biotechnology
inventions like genetically engineered plants, animal gene, DNA, and the like
is indisputable. Therefore, the utility or industrial application of biotechnology
inventions is accepted and assumed in India.
The inventions of biotechnology are very much useful in different
sectors, specifically and substantially. Biotechnology is being vastly used in
different sectors such as agriculture, medical, chemical industry, animal
husbandry, and many others. Biotechnology has brought up innovative
medical treatments and surgical procedures that are useful for the society.
Biotechnology inventions are useful in treating pollution, poultry, fisheries,
forestry, and others. This technology has got enormous importance in present-
day life.
5.Written description of biotechnology inventions in India.
India is no different as far as written description of biotechnology inventions
are concerned. The Patents Act states that the patent application shall be
accompanied by the complete specification or provisional specification of the
invention. The application must be accompanied by provisional or
301. Genentech v. Welcome Foundation, T (292/85 (1988) O.J EPO 275, (1989) R.P.C 613.
302. Ibid., also FN T 19/90 (1990) O.J. EPO 476, Tech Bd. App; (1991) E.P.O.R. 525, Ex.,
Biogen v.
Medeva (1997) R.P.C 1. H.L.
303. Genentech v. Welcome Foundation, Fn T (292/85 (1988) O.J EPO 275, (1989) R.P.C
613; Harvard Onco-mouse, FNT 19/90 (1990) O.J EPO 476,Tech Bd. App; (1991)
E.P.O.R.525, Asahi Kasu Kogyo’s application, FN (1991) R.P.C. 485. H, Collaborative
Research application decision T81/87 (1990) O.J EPO 250.
304. Asahi Kasu Kogyo’s application (1991) R.P.C. 485. H, Collaborative research application
Decision T81/87 (1990) O.J EPO 250, Biogen v. Medeva (1997) R.P.C 1. H.L
305. Ibid.
complete specification. The specification must describe the invention, its
operation or use with the help of drawings if necessary. If the applicant does
not give complete specification of the invention at the time of filing the
application, he can file the complete specification within twelve months
thereafter. Further, the specification must disclose the best mode of
performing the invention, which is known to the applicant. In case of claiming
the priority of an application filed earlier, priority shall be given only when
the earlier application does give the complete specification of the invention to
enable a person skilled in the art to practice the invention in the best possible
way. Further, the speciation shall define the scope of the claimed invention
with claim or claims on the invention.
The Patents Act was amended latest by 2005 keeping in mind the
necessity of deposit of invention in case of biotechnology patents. The
amendment recognizes the Budapest Treaty for facilitating the deposit of
biotechnology inventions for the sake of patent procedure. A biotechnology
patent application must be accompanied by a deposit of the invention in any
recognized depository as recognized by the government of India through
notification in the official gazette. The name and address of the depository and
the date of the deposit shall be mentioned in the application. Further, the
access number issued to the deposited invention shall also be mentioned in the
application. There is no case law development with regard to the fulfillment of
written description requirement by biotechnology inventions in India. Since
the biotechnology industry is in an infant stage in India and only since 2005
India is granting patents on biotechnology invention, there is no substantive
development of law in this regard. However, the disclosure of the invention
through specification while making the patent application is a prerequisite for
he grant of patent.
In contrast to the patent law of the United States of America and of the
European Union the Indian Patents Act mandates the disclosure of source and
geographical origin of the biological material used in producing the claimed
biotechnology invention. The Biological Diversity Act, 2001 read with the
Patents Act states that the use of biological resource in producing the claimed
biotechnology invention shall be disclosed and mentioned in the patent
application to share the benefits of the patents to the geographical
The Patents Act, 1970 as stands amended latest by 2005. Section 9: Provisional and
complete specification.
The Patents Act, 1970, Section 10 Contents of specification.
The Patents Act, 1970 as stands amended latest by 2005. Section 10, Sub-clause: 4(b)
The Patents Act, 1970, Section 11 Priority dates of claims of a complete specification.
Patents Amendment Act 2002 See supra 17, pp. 38–9.
Patents Act of India as amended in 2005, Section 10; sub-clause 4(d)(ii)(D).
Biological Diversity Act, 2001.
The Indian Patents Act as amended in 2005.
regions, which conserved the resource. The TRIPS agreement does not require
the mentioning of the origin of the resources. However, the convention on
biological diversity (CBD) states that the origin of the biological resources
used shall be acknowledged and the geographical regions shall be given a
share in the benefits of such usage. In fact, it is a crucial issue where the CBD
and the TRIPS do contradict. However, having ratified both the agreement,
India does provide in its patent laws that the patent application claiming a
biotechnology invention is complete only when it discloses the source of the
resources used.
Written description of the invention is a core principle of patent law. An
invention shall be described in a clear and comprehensive manner in order to
enable a skilled person in the art to practice the invention. The requirement of
written description has been applied to biotechnological invention in varied
form. In case of biotechnological invention the written description has to
furnish the chemical and physical properties of the inventions along with its
structure and sequences. However, in every case, it is not possible to describe
a biotechnological invention in a clear and comprehensive manner. Due to the
fact that biotechnological inventions are living beings it may not always be
possible to describe the invention as required under the patent laws. So the
practice of depositing the claimed invention has been adopted to satisfy the
written description requirement. It is accepted that the deposit of the invention
fulfils the requirement of written description. A deposit of the invention serves
as an additional security to the inventor in claiming the patent and also helps
in rebutting claims of invalidity against the patent.
A biotechnology invention, which satisfies the requirements of novelty,
non-obviousness, utility, and written description is patentable provided the
invention falls within the range of matters which are patentable. The patent
law states that a biotechnology invention, which is not a patentable subject
matter, cannot be patented though it may satisfy the requirements of
patentability. It is a settled principle in the patent law that a biotechnology
invention is patentable only when it does fall within the purview of patentable
subject matter. Difficulties arise in determining the novelty and non-
obviousness of biotechnology inventions. The fact that biotechnology
inventions are living beings which are manipulated from their earlier position
of natural existence to possess certain desired characteristics give rise to
certain difficulties. As per the present patent law it is believed that things or
living beings existing in nature are products of nature, which are not
patentable. It is also believed that addition of human ingenuity to these
products of nature renders them products of man. Therefore, the difference
between products of nature and products of man and the point from where a
product of nature becomes a product of man are very significant in deciding
the novelty and non-obviousness of biotechnology inventions. However, the
utility of biotechnology inventions is undisputed. Further, the satisfaction of
the requirement of written description is also problematic in case of
biotechnology inventions. It is felt that it may not be possible to describe a
biotechnology invention in a clear and complete manner. Therefore, difficulty
arises in satisfying the requirement of written description. Hence, in order to
compensate the non-fulfillment of written description requirement deposit of
the invention is recommended. It is believed that deposit of the invention
serves the purpose of describing the invention in order to enable the person
skilled in the art to practice the invention in the best possible way. With the
coming into being of the TRIPS agreement throughout the world patent laws
have been harmonized. Now in all the member states of the TRIPS agreement,
the requirements of patentability of biotechnology inventions are uniform.
Therefore, a biotechnology invention satisfying the requirements of novelty,
non-obviousness, industrial application, and written description or deposit of
the invention is patentable throughout the world.
5.4 PATENTING OF MICRO ORGANISMS
5.5 PATENTING OF HUMAN CELLS AND GENETIC MATERIAL
CHAPTER 6
6.1COMAPARATIVE STUDY IN USA,EU AND INDIA
6.1. USA
6.2. EUROPEAN UNION
6.3.INDIA
6.1.USA
PLANT:
Patenting of Plant-related inventions
In the US, there are three forms of protection for plant-related inventions.
These are Utility Patents, Plant Patent Act (PPA), Plant Variety Protection Act
(PVPA). The utility patents and the plant protection patents are granted by
USPTO while the PVPA is granted by Plant Variety protection Office
governed by USDA. Utility patents awarded in the US cover conventionally
bred varieties or genetically modified plants. A number of examples of utility
patents have been give in the later sections.
Plant patent is a right granted by the government to an inventor who has
invented or discovered and asexually reproduced new plant variety other than
tuber-propagated plant or plant found in uncultivated state. This grant lasts for
20 years (in the US) from the date of filing the application, protects the
inventor’s right to exclude others from asexually reproducing, selling or using
the plant so reproduced. This protection is limited to one plant variety. A sport
or mutant of a patented plant is not considered to have same genotype as that
of the parent plant. Hence, such plants are separately patented instead of being
covered by the plant patent of the parent plant.
The first plant patent was issued in 1931 to Henry Bosenberg of New
Brunswick, NJ, for a climbing or trailing rose. This invention was for
climbing roses bearing true blooming character. There was another plant
patent for a rose plant named ‘Breapum’ granted to Ezio Brea in 2003
(USPP14, 226 P3). The new and distinct cultivar had the unique
characteristics of long erect flowering stems, creamy white flowers and
orange hips arranged in sprays. A patent for Chrysanthemum plant named
‘Zembla’ (US PP14, 052 P2) was granted which was for an invention distinct
in possessing decorative inflorescence and possessing excellent post-
production longevity.
Under Section 3(j) of Indian Patents Act, 1970 plants are not considered
patentable subject matter Under Section 3(h) of the Act, and methods of
agriculture and horticulture are not patentable. Similarly, essentially biological
processes for the production or propagation of plants are not patentable under
Section 3(j). Section 3 of the Patents Act has been dealt with in the earlier
sections. Plant varieties may be protected in India under PVPFRA which has
recently come into force.
Tissue Culture Techniques and Genetic Transformation of
Plants
An important area of research in plants relates to tissue culture and genetic
engineering of plants. The intellectual property scenario on genetic
transformation of plants is quite complex. The subject matter considered
patentable under this category involves the following:
Transformation techniques: there are various transformation methods
basically classified into two categories, which permit introduction of genetic
material into plants to render them with properties like disease resistance,
improved seed quality, and insect resistance.
Agrobacterium-mediated transformation is an indirect method of
transformation that involves Agrobacterium tumefaciens, which is a common
soil bacterium that naturally inserts its genes into plants and uses the
machinery of plants to express those genes in the form of compounds that the
bacterium uses as nutrients. Agrobacterium-mediated transformation has been
dealt with in detail in Chapter 15, Section 15.12.1.
Patents related to transformation of dicot plant
US5, 024, 944 Transformation, somatic embryogenesis and whole
plant regeneration method for Glycine species
US5, 986, 181 Transformation and regeneration of fertile cotton plants
EP910239 Transformation of cotton explants with Agrobacterium
WO0042207 Transformation of a soybean germline with
Agrobacterium
Patents related to transformation of monocot plants
US6,720,488 Transgenic maize seed and method for controlling
insect pests
WO05096806 Edible vaccine in the form of rice
AU3402897 Transformation of wheat with Agrobacterium
AU7134298 Transformation of sorghum with
Agrobacterium/Pioneer Hi-Bred
There exists large number of patents where Agrobacterium has been
used for the transformation of dicotyledonous plants. Examples of some of
these patents are given in Table 22-4.
Transformation using Agrobacterium is now becoming popular among
the monocots. Some of the important patents that were granted in this regard
are listed below in Table 22-5.
Direct method of transformation, where direct uptake of the genetic
material by plant cell occurs (see Chapter 15, Section 15.12.2 for details) are
also in use. Some of the patents that use these techniques have been listed
below in Table 22.6.
Regeneration Protocols. For genetic transformation of plants an
excellent system of regeneration is necessary. There are many patents granted
for methods of regeneration using different explants such as leaves, roots,
hpyocotyls, cotyledons and seeds. A patent has been granted for a method for
regenerating cotton plant from explant tissue comprising regenerating
embroygenc callus from a cotton tissue explants cultivated on cotton initiation
media not supplied with exogenous plant hormones (EP910239B1 and US5,
846, 797).
Explants: The different types of explants that have granted patents are
listed below in Table 22-7.
Other patentable component: Transformation vectors, selectable marker
genes, reporter genes, promoters and enhancers are some of the important
components that are also patentable. A list of these that were used in golden
rice manufacture is given below in Table 22-8.
Genetically modified plant: Genes conferring resistance to insect pests and
various fungal, viral and bacterial disease have been successfully introduced
in variety of crop plants. Similarly, transgenic plants containing genes for
drought and salt tolerance, improved quality for value addition and increased
shelf life are produced through genetic transformation. The classic example is
of Bt transgenic plants into which the genes elaborating the insecticidal toxins
of Bacillus thuringiensis have been introduced. However, in India since plants
per se are not patentable, patents for genetically modified plants are not
allowed.
More than 400 patents have been granted on Bt isolates, strains, genes,
Bt toxin receptors and on specific proteins toxic to a given insect class or pest.
Bt toxin receptor BT R2 from Pectinophora gossypiella (pink bollworm) has
been patented (US6,645,497). A USBTS02618A, BTS02654B and
BTS02652E strains. Patents have been granted to polynucleotide
compositions encoding broad spectrum endotoxins (US6,645,497;
US6,538,109; US6,521,442; US6,448,226). Plasmid(s) containing
heterologous DNA coding for Bt crystal protein in E.coli is protected under
US patent (US4,467,036). A US patent (US6,326,169) disclose polynucleotide
compositions encoding Cry 1 Ac/Cry 1F chimeric endotoxins. Bt cry ETI
toxin gene and protein toxic to lepidopteran insect, Plutella xylostella
(Dimondback moth), has been patented (US5,356,623). This patent also
discloses the method of controlling susceptible lepidopteran insects by
applying the effective amount of insecticidal toxins to the host plant. A
European patent (EP0358557B1) discloses a new DNA sequence that encodes
the 130 kDa protoxin, the ‘Bt 18 protoxin’, from the genome of the B.
thruingiensis var. darmstadiensis HD -146. This protoxin cleaves into 62 kDa
of active toxin and is highly active against Lepidoptera species from the
Noctuidae family such as Spodopter species and Manducasxta. Five novel
nematocidal cry gene sequences are disclosed in European patent
(EP0462721). Two crylgene sequences are disclosed in European patent
(EP0401979).
Patents for modifying the Bt gene to optimize expression of the
insecticidal protein in plants have also been granted. A US patent
(US6,242,241) disclosed novel synthetically modified Bt chimeric crystal
protein having improved insecticidal activity against coleopteran, dipteran and
lepidopteran. This patent also covers nucleicacid encoding for these novel
peptide, methods of making and using these genes, and proteins, method for
the recombianant expression and transformation of suitable host cells,
transformed host cells, and transgenic plants expressing the said Bt toxin. Two
US patents (US6,033,874; US6,423,828) have been granted where novel
synthetically-modified B. thuringiensis cry 1C gene sequence encoding
endotoxins having lepidopteran-specific insecticidal activity has been
disclosed.
More than 482 patents had been filed or granted for inventions related
to Bt crops, some 95 of these patents involve transgenic plants. US patents
have been granted for the production of transgenic maize expressing the
synthetic Bt protein (US5,484,956; US6,720,488). US patent (US6,720,488)
discloses the method of production of transgenic maize expressing synthetic
Bt insecticidal crystal protein genes in which the codon usage has been altered
to increase expression of the Bt gene.
ANIMAL:
Genetically Modified Organisms
Unicellular Organisms
the patentability of unicellular organisms was questioned and clarified by the
US Supreme Court in Chakrabarty’s case. In Diamond v. Chakrabarty, which
is considered to be the most important biotech case relating to patentable
subject matter, the United States Supreme Court, by holding that everything
under the sun made by man is patentable, cleared all doubts and opened the
gates for patentability of biotech inventions. The case involved Chakrabarty’s
invention of a genetically modified pseudomonas bacterium capable of
degrading oil spills and a process by which four different plasmids, capable of
degrading four different oil components, could be transferred to and
maintained stably in a single Pseudomonas bacterium, which by itself had no
capacity for degrading oil. Chakrabarty’s patent claims were of three types:
first, process claims for the method of producing the bacteria; second, claims
for an inoculum comprising a carrier material floating on water, such as straw,
and the new bacteria; and third, claims to the bacteria themselves. The patent
examiner accepted the claims falling into the first two categories, but rejected
claims for the bacteria. The decision rested on two grounds:
(1) micro-organisms are ‘products of nature’, and (2) as living things the
Pseudomonas bacteria are not patentable subject matter under section 101
The US Supreme Court rejected both the arguments. It rejected the product of
nature argument by stating that Chakrabarty had produced a new bacterium
with markedly different characteristics from any found in nature. The court
went on to say that the test for determining whether an invention falls within
the scope of ‘Product of nature’ is whether the invention in question involves
a hand of man. If yes, the invention is not product of nature or naturally
existing. If no, it is naturally existing and, therefore, not patentable. As the
Pseudomonas bacterium in question involved the hand of man in inserting
four different plasmids into it, the court held that it was not naturally existing
and therefore patentable. The court rejected the second argument by holding
that micro-organisms were patentable as manufactures or compositions of
matter and that the Congress did not intend to keep them out of the scope of
subject matter The decision in the Chakrabarty case opened the gates for
patentability of genetically engineered unicellular organisms and processes
involved in genetic engineering. After this decision, non-naturally existing
unicellular organisms became patentable in USA. Since then micro-organisms
have been considered by USPTO as manufactures or compositions of matter
and thus numerous patents have been granted to micro-organisms.
Multicellular Organisms:
In the year 1987, the USPTO announced that non-naturally occurring, non-
human multicellular organisms are patentable. The notice, signed by Donald J.
Quigg, Commissioner of Patents and Trademarks stated that, ‘as a result of the
Board’s decision in Ex parte Allen, the USPTO considers non- naturally
occurring, non-human multicellular living organisms, including animals, to be
patentable subject matter within the scope of section 101.The case involved a
patent application over polyploid oysters and a process of inducing polyploidy
in them. The examiner allowed claims relating to the process but rejected
claims over the oysters stating that they were living organisms, which were
not a patentable subject matter under section 101. The Board of Patent
Appeals and Interferences reversed the examiner’s rejection by holding that
the polyploid oysters were subject matter, as they did not naturally exist and
required the involvement of the hand of man in creating them. Relying on the
decision in Chakrabarty’s case the Board stated that the relevant enquiry for
subject matter was not the difference between living and inanimate things, but
between products of nature and human-made inventions After the oyster
decision USPTO granted a patent to an invention relating to a transgenic
mouse into which an oncogene sequence was introduced. The mouse was
created for study of breast cancer and was called oncomouse. The USPTO
granted a patent over the mouse in the year 1988, one year after ex parte
Allen. The Harvard mouse patent can be said to be the first patent that
expanded the scope of patent protection to multicellular organisms. After
oncomouse, a number of patents were granted to transgenic animals including
mice, rabbit, etc
In a case relating to patentability of genetically modified plants3, the US
Supreme Court held that newly developed plant breeds could be protected
under the utility patent statute and concluded that neither the Plant Protection
Act nor the Plant Variety Protection Act bars obtaining utility patents for
plants. The court in this case held a genetically modified corn plant to be
patentable subject matter as it involves human intervention. The decision
elucidates the fact that genetically modified plants are patentable in USA.
Genes:
Gene sequences, ESTs and gene probes are patentable in USA. As there
has not been any judicial scrutiny of patentable subject matter relating to gene
or DNA sequences, the interpretation of USPTO stands good. The USPTO has
extended patent protection to isolated DNA, RNA and proteins under section
101 stating that gene and protein sequences are new compositions of matter
resulting from human intervention as opposed to naturally occurring products,
which are not patentable. The exclusion of any product of nature is not a
hurdle to patenting of gene or DNA sequences because isolated and purified
sequences are not naturally existing and contain only the regions of naturally
existing DNA that code for proteins. A large number of patents have been
granted to DNA sequences based on the aforementioned analysis. The number
of patents over gene sequences increased after NIH filed patent applications
over cDNA sequences and ESTs in the early 1990s.4 Organizations like
Human Genome Sciences, Millennium Pharmaceuticals, Incyte
Pharmaceuticals, Celera Genomics, etc., filed and acquired hundreds of
patents over DNA sequences
The US Supreme Court recently declined to decide the validity of aprocess
patent relating to an amino acid. The patent at issue related to methods for
detecting Cobalamine (Vitamin B12) and Folate (Folic Acid) deficiency by
determining the levels of homocysteine in the body. Claim of the patent
claims a method for detecting deficiency of cobalamine or folate in warm-
blooded animals comprising the dual steps of assaying a body fluid for an
elevated level of total homocysteine and correlating such elevated level in the
said body fluid with deficiency of cobalamine or folate Metabolite, the
licensee of the patent, sued Laboratory Corporation, the sub-licensee, for
patent infringement in the District Court of Colarodo. The district court held
that Laboratory Corporation, by supplying the results relating to levels of
homocysteine in human body to doctors was liable for contributory
infringement and granted damages to the tune of seven million dollars. The
court said that the doctors, by correlating levels of homocysteine to Vitamin B
deficiency directly, infringed claim of the patent. As Laboratory Corporation
supplied the data to make such an analysis, it said that Laboratory Corporation
was liable for contributory infringement. On appeal the Federal Circuit upheld
the decision of the district court Thereafter, Laboratory Corporation filed a
writ of certiorari before the US Supreme Court claiming patent invalidity The
US Supreme Court admitted the writ of certiorari filed by Laboratory
Corporation, challenging the decision of the Federal Circuit on validity of
claim 13 of the patent. The question to be decided by the court was ‘Whether
a vaguely worded patent claim directing a party simply to correlate test results
can validly claim a monopoly over a basic scientific relationship used in
medical treatment such that any doctor necessarily infringes the patent merely
by thinking about the relationship after looking at a test result. Professor Jon
Barton of Stanford Law School and Affymetrix filed an amicus brief before
the US Supreme Court submitting that upholding claim of the patent valid
would expand the scope of patentable subject matter to such an extent that one
may effectively own a natural biochemical relationship by excluding others
from any and all testing of that relationship. They believed that such a broad
scope of patentable subject matter would nullify the doctrine of law of nature
and would impact genetic research adversely. Under such broad patentable
subject matter, patents would be available for relationship of a gene to a
disease/amino acid, or relationship between genes of different individuals, and
so on. They also submitted that grant of such broad patents over biological
relationships would block genetic research and chill gene testingThe US
Supreme Court dismissed the writ of certiorari as improvidently granted. By
dismissing the writ, the Supreme Court upheld the decision of the Federal
Circuit, which means that claim of the patent is valid and that Laboratory
Corporation is liable for patent infringement. As a result the Supreme Court
has broadened the scope of subject matter by narrowing the doctrine of
product of nature. According to this decision, discovery of a relationship
between a gene and a disease can get a patent
Gene Therapy:
Genetic therapy is used to correct genetic disorders and can be
considered to be a method of medical treatment. The expansive scope of
subject matter under section 101 allows the right to patent a method of
medical treatment as a process. However, the patent statute under section
287(c)(1)4 abrogates the remedy available for its infringement, thus nullifying
the right to patent. Section 287(c)(1) states that infringement provisions shall
not apply to a medical activity performed by a medical practitioner or a
related health care entity. The term medical activity has been defined in the
same section to include performance of any medical or surgical procedure.
These provisions were added to the statute in the year 1996 through an
Omnibus Consolidated Appropriations Act. They deny the patentee a remedy
for infringement of a medical or surgical procedure. Therefore, though gene
therapy, which is a medical method, is patentable subject matter, a patent over
it is ineffective as it is not enforceable
Human beings: Human beings are not patentable in USA. The Patent and Trademark Office
has stated in a notice that human multicellular living organisms are not a
patentable subject matter within the scope of section 101. A patent claim
including or covering a human being at any stage of development is
considered by the USPTO as a non-statutory subject matter under Section
101.2 Though the Manual of Patent Examining Procedure (MPEP) does not
expressly address claims directed to a human embryo, in practice, examiners
would treat such claims as non-statutory
The US Patent and Trademark Office recently rejected a 1997 patent
application, filed by Dr Stuart Newman of New York Medical College
covering fusion of embryonic human and animal cells to create chimeras for
medical research. The patent application related to a mammalian embryo
developed from embryo cells, a mixture of embryo cells and embryonic stem
cells, or embryonic stem cells exclusively, in which at least one of the cells is
derived from a human embryo, a human embryonic stem cell line, or any
other type of human cell, and any cell line, developed embryo, or animal
derived from such an embryo.5 The applicant’s objective was to prevent grant
of patents over human-based living organisms either by obtaining a patent on
technology he would not use or by getting the USPTO to declare such
inventions contrary to law. The USPTO’s rejection was based on the ground
that the patent would violate the thirteenth amendment’s ban on slavery and
would be inconsistent with the constitutional right to privacy
6.2. EUROPEAN UNION
Genetically Modified Organisms :
Unicellular Organisms:
Article 53(b) of the European Patent Convention (EPC) excludes plant and
animal varieties and essential biological processes for the production of plants
and animals from the scope of patent protection but provides an exemption fo
patenting microbiological products or processes. Rule 23b(6) of the
Implementing Regulations provides that a ‘Microbiological process’ means
any process involving or per formed upon or resulting in microbiological
material and rule 23c(c) provides that a microbiological or other technical
process, or a product obtained by means of such a process other than a plant or
animal variety is patentable subject matter. It was held in T356/93 that micro-
organisms are patentable as products of
microbiological processes, and micro-organisms were defined as generally
unicellular organisms with dimensions beneath the limits of vision, which can
be propagated and manipulated in a laboratory. As per the aforementioned
provisions when a process of genetic engineering if applied on a micro-
organism the resultant micro-organisms become patentable subject matter as
they come within the ambit of microbiological process and product.
Multicellular Organisms:
Article 53(b) of EPC provides that European patents are not available for
plant or animal varieties and essentially biological processes for the
production of plants or animals.5 Rule 23c of the regulations provides that
plants or animals are patentable if the technical feasibility of the invention is
not confined to a particular plant or animal variety.6 Genetically modified
animals and plants have been held to be patentable as they fall outside the
scope of animal or plant variety
‘Plant variety’ has been defined in the regulations as any plant grouping
within a single botanical taxon of the lowest known rank, which grouping,
irrespective of whether the conditions for the grant of a plant variety right
are fully met, can be
Defined by the expression of the characteristics that results from a
given genotype or combination of genotypes
Distinguished from any other plant grouping by the expression of at least one
of the said characteristics, and
Considered as a unit with regard to its suitability for being propagated
unchanged
A plant variety is considered patentable if it falls outside the meaning of the
term plant variety defined in the implementing regulations. The biotechnology
directive provides that a plant grouping which is characterized by a particular
gene (and not its whole genome) is not covered by the protection of new
varieties and is, therefore, not excluded from patentability even if it comprises
new varieties of plants. As per the directive transgenic plants fall outside the
scope of the definition of plant variety and are, therefore, patentable subject
matter
In a case involving Novartis, relating to patentability of transgenic plants into
which DNA had been inserted using recombinant technology, the Technical
Board of Appeals held that genetically modified plants were patentable
subject matter. The Technical Board observed that as genetically modified
plants were not conceived at the time of drafting, it could be concluded that
they do not fall within the scope of exclusion to patentable subject matter. It
further stated that if a genetic modification can be applied to more than one
variety, the invention is patentable subject matter as it falls outside the scope
of exclusion that is plant variety
As the term ‘animal variety’ has not been defined in the Convention or
Regulations, patentability of genetically modified animals depends on the
interpretation of EPO. Patentability of genetically modified animals has been
tested and approved through the decision of the Technical Board of Appeals in
the Oncomouse case. The case related to a genetically altered mouse, which
involved inserting an activated oncogene to develop cancer in the mouse. The
patent application was initially rejected by the examination division based on
the reasoning that the Oncomouse falls within the scope of Article 53(b),
which excludes animal varieties from the scope of patentable
subject matter.1 The examination division interpreted the term ‘animal
variety’ to include all animals. On appeal, the Technical Board held that the
wording of Article 53(b) indicates that all animals are not excluded from
patentable subject matter because the usage of both the terms ‘animal
varieties’ and ‘animals’ in the same provision illustrates that the legislature
did not intend to exclude all animals from patentability. As rodents and
mammals form a taxonomical unit higher than any animal variety, the Board
held that they are patentable. On remand, the examination division granted a
patent on the mouse based on the aforementioned interpretation. As it stands
today, genetically modified multicellular organisms including rodents and
mammals are patentable subject matter in Europe
Genes
The EPC is silent about patentability of genes but the implementing
regulations that adopted the EU Biotechnology Directive has specific
provisions dealing with patentability of genes. The implementing regulations
provide that biological material, which is isolated from its natural
environment or produced by means of a technical process even if it previously
occurred in nature, is patentable. Biological material has been defined as any
material containing genetic information and capable of reproducing itself or
being reproduced in a biological system. A gene is considered a biological
material because it can be reproduced in a biological system such as a cell or
bacteria and is patentable if isolated from its natural state. Rule 23e
specifically mentions that gene sequences are patentable. It provides that
though the sequence or partial sequence of a gene cannot constitute a
patentable invention, an element isolated from the human body or otherwise
produced by means of a technical process, including the sequence or partial
sequence of a gene, may constitute a patentable invention, even if the structure
of that element is identical to that of a natural element. Based on the
implementing regulations, partial and complete gene sequences are patentable
under the EPC In a case relating to patentability of a DNA sequence coding
for Human H2 Relaxin, the Opposition Division of EPO held that the DNA
sequence was patentable subject matter. While holding so, the Opposition
Division observed that if a substance found in nature has first to be isolated
from its surroundings and a process for obtaining it is developed, that process
is patentable. Moreover, it also observed that if this substance can be properly
characterized by its structure and it is new in the absolute sense of having no
previously recognized existence, the substance per se may be patentable.
Based on the aforementioned principle, the Opposition Division held that the
DNA sequence of Human H2 Relaxin was patentable subject matter because
Human H2 Relaxin had no previously recognized existence, the patent holder
developed a process for obtaining H2 Relaxin and the DNA encoding it and
the patent holder characterized these products by their chemical structure and
found a use for the protein. The Opposition Division went on to state that it
was justified to grant patent protection in this case as H2 Relaxin was made
available to the public for the first time. After this decision, EPO has granted a
number of patents over different types of genes till date.
Gene Therapy
Article 52, clause (4), excludes methods of treatment of the human or
animal body by surgery or therapy and diagnostic methods practised on
humans from the scope of patentable subject matter. The law relating to
patentability of medical methods has been elaborated by decisions of the EPO
board of appeals and other national boards. These decisions have laid down
certain guidelines to be followed while deciding upon the patentability of
surgical, therapeutic and diagnostic methods
The term ‘surgery’ has been held by the Board to include not only invasive
operations, but also non-invasive procedures such as repositioning.
Therapeutic methods have been held to be not patentable if they involve a
therapy on human or animal body. The term ‘therapy’ has been defined by the
EPO to include anything that relates very broadly to the treatment of a disease
in general or to a curative treatment as well as to the alleviation of the
symptoms of pain and suffering.6 The patentability of a ‘therapy’ depends
upon the nature of the treatment. Generally cosmetic methods are patentable
in EPO.7 As per the Board, in vivo diagnostic methods are barred from
patentability but in vitro methods are patentable. In the light of the decisions,
surgical and therapeutic methods using genes would not be patentable prima
facie. However, diagnostic methods using genes would be patentable provided
they are in vitro. There is no ban on patentability of implements and kits used
for genetic therapies
Human Beings: Article 53(a) of the European Patent Convention provides that inventions,
the publication or exploitation of which would be contrary to public order or
morality, are not patentable. Rule 23d of the regulations provides that under
Article 53(a), European patents shall not be granted in respect of
biotechnological inventions which, in particular, concern processes for
cloning human beings, processes for modifying the germ line genetic identity
of human beings, uses of human embryos for industrial or commercial
purposes and processes for modifying the genetic identity of animals which
are likely to cause them suffering without any substantial medical benefit to
man or animal, and also animals resulting from such processes. Further, Rule
23e provides that the human body, at various stages of its formation
and development, and the simple discovery of one of its elements is not
patentable. However, elements isolated from the human body or otherwise
produced by means of a technical process are patentable even if the structure
of that element is identical to that of a natural element. As per the provision,
human beings or parts/elements of human body and processes of cloning or
altering them are not patentable but elements isolated from human body
through a technical process are patentable in Europe
In a recent case, the examination division of EPO rejected a patent relating
to human embryos stating that it is in violation of Article 53(a) of EPC. The
case related to a patent application titled ‘primate embryonic stem cells’ filed
by Wisconsin Alumni Research Foundation (WARF). The examination
division rejected the application as it did not comply with Article 53(a) of
EPC in conjunction with rule 23d(c) of EPC. Rule 23d(c) of EPC precludes
the grant of a European patent for the use of human embryos for industrial of
commercial purposes
The examination division considered that the application related to the
generation of human embryonic stem cell cultures where human embryos
were described in the application as filed as indispensable starting materials,
which meant a use thereof for industrial purposes within the meaning of rule
23d(c) of EPC. As the description of the application in suit provided only one
source of starting cells, namely pre-implantation embryos, the examination
division thus regarded it as irrelevant that the claimed subject matter related to
cell cultures and not a method of their production. WARF appealed to the
Technical Board, which referred the case to the enlarged Board for clarifying
the scope of exclusion of patentability of human embryo
6.3.INDIA:
PLANTS RELATED INVENTIONS:
Under Section 3(j) of Indian Patents Act, 1970 plants are not considered
patentable subject matter Under Section 3(h) of the Act, and methods of
agriculture and horticulture are not patentable. Similarly, essentially biological
processes for the production or propagation of plants are not patentable under
Section 3(j). Section 3 of the Patents Act has been dealt with in the earlier
sections. Plant varieties may be protected in India under PVPFRA which has
recently come into force.
As per the Indian Patent Act, any product or process is patentable subject
matter.1 However, the Act provides a long list of inventions that are excluded
from patentable subject matter, which includes certain genetic inventions.
Living Organisms, Genes and Gene Therapies:
The Indian Patent Act prohibits patents on discovery of any living thing
occurring in nature. It provides that plants and animals in whole or any part
thereof including seeds, varieties, species, and essentially biological processes
for production or propagation of plants and animals are not patentable subject
matter. However, the Act allows patents for micro- organisms and
microbiological processes. In a case, the Controller of Patents rejected a
patent application over a vaccine for infectious bursitis virus on the ground
that it is a living organism. The Calcutta High Court reversed the decision of
the controller holding that a living micro-organism constitutes patentable
subject matter as a manufacture. Based on this decision, it can be said that in
India, genetically modified micro-organisms are patentable as per the statute
and case law
Genetically modified multicellular organisms including plants, animals,
human beings, and their parts are not patentable in India as per section . The
Manual of Patent Practice and Procedure provides that biological materials
such as recombinant DNA, plasmids, and processes of manufacturing thereof
are patentable if they are produced by substantive human intervention .
Gene sequences and DNA sequences having disclosed functions are
considered patentable in India.6 The processes for cloning human beings or
animals, processes for modifying the germ line, genetic identity of human
beings or animals, uses of human or animal embryos for any purpose are not
patentable as they are against public order and morality
The list of non-patentable inventions in India also includes any process for the
medicinal, surgical, curative, prophylactic, diagnostic, therapeutic, or other
treatment of human beings or any process for a similar treatment of animals to
render them free of disease or to increase their economic
value. As genetic therapies are therapeutic and are meant for rendering an
animal or human being free of disease, they are not patentable in India
COMPARATIVE ANALYSIS OF PATENTING ON LIVING
ORGANISMS RELATED TO SUBJECT MATTER IN USA,
EUROPEAN UNION AND INDIA
patentable subject matter gives countries the power to define the size of
public and patent domains in their respective countries. By defining the list of
subjects eligible for subject matter and list of subjects excluded from subject
matter, a government lays down straightforward entries or exclusions from the
scope of patent system. The differences in the scope of patentable subject
matter of LIVING ORGANISMS based inventions in USA, Europe, and India
gives rise to variances in patentability. the patentability of genetically
modified organisms, genes, gene therapies, and human beings in these
countries based on the scope of patentable subject matter. There is no
variation of the subjects eligible for patentability when it comes to genetically
modified unicellular organisms, genes, and genetically modified human
beings. While genes and genetically modified unicellular organisms are
patentable in all three countries, genetically modified human beings are not
patentable in all three countries. However, there is a variation in the scope of
subject matter when it comes to genetically modified multicellular organisms
and gene therapies. While all genetically modified multicellular organisms are
patentable in USA, only genetically modified mammals and genetically
modified plants are patentable subject matter in Europe and genetically
modified multicellular organisms are not patentable subject matter in India.
As a result all genetically modified multicellular organisms are eligible for
patentability in USA and only genetically modified mammals and plants are
eligible for patentability in Europe, which means that non-mammalians and
plants not genetically modified are in public domain in Europe and all
genetically modified multicellular organisms fall into the public domain in
India. Above illustrates the variance in patent/public domain when it comes
to genetically modified multicellular organisms. In case of gene therapies,
they are patentable in USA but not patentable in Europe and India. So, gene
therapies fall within the scope of eligible patent domain in USA and into the
public domain in Europe and India.
CHAPTER 7
7.1 CONCLUSION AND SUGGESTIONS
7.2 BIBLIOGRAPHY
7.3 WEBLIOGRAPHY